Trial Outcomes & Findings for Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (NCT NCT01881828)
NCT ID: NCT01881828
Last Updated: 2020-03-03
Results Overview
Hemoglobin A1c is a measure of glycemic control over approximately the past 3 months
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
164 participants
Primary outcome timeframe
0-26 weeks
Results posted on
2020-03-03
Participant Flow
Participant milestones
| Measure |
Metformin
Metformin 2000 mg per day
Metformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
|
Oral Placebo
A central pharmacy will compound a placebo to match the metformin tablets.
The placebo product will contain the following components:
* Micosolle™, silica based excipient
* Silicified Micro Crystalline Cellulose, National Formulary
* Safflower Oil, United States Pharmacopeia
* K-30 Povidone Powder
* Magnesium Stearate, National Formulary (Vegetable source)
* Fumed Silica, National Formulary
oral placebo
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
69
|
|
Overall Study
COMPLETED
|
71
|
69
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Metformin Therapy for Overweight Adolescents With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Metformin
n=71 Participants
Metformin 2000 mg per day
Metformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
|
Oral Placebo
n=69 Participants
A central pharmacy will compound a placebo to match the metformin tablets.
The placebo product will contain the following components:
* Micosolle™, silica based excipient
* Silicified Micro Crystalline Cellulose, National Formulary
* Safflower Oil, United States Pharmacopeia
* K-30 Povidone Powder
* Magnesium Stearate, National Formulary (Vegetable source)
* Fumed Silica, National Formulary
oral placebo
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
15.4 years
STANDARD_DEVIATION 1.7 • n=99 Participants
|
15.1 years
STANDARD_DEVIATION 1.8 • n=107 Participants
|
15.3 years
STANDARD_DEVIATION 1.7 • n=206 Participants
|
|
Age, Customized
12-15 years
|
43 years
n=99 Participants
|
47 years
n=107 Participants
|
90 years
n=206 Participants
|
|
Age, Customized
16-19 years
|
28 years
n=99 Participants
|
22 years
n=107 Participants
|
50 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
92 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
51 participants
n=99 Participants
|
52 participants
n=107 Participants
|
103 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
13 participants
n=99 Participants
|
11 participants
n=107 Participants
|
24 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Duration of Diabetes
|
7.5 years
STANDARD_DEVIATION 3.6 • n=99 Participants
|
6.4 years
STANDARD_DEVIATION 3.0 • n=107 Participants
|
7.0 years
STANDARD_DEVIATION 3.6 • n=206 Participants
|
|
Duration of Diabetes (group)
1-2 Years
|
5 years
n=99 Participants
|
9 years
n=107 Participants
|
14 years
n=206 Participants
|
|
Duration of Diabetes (group)
3-5 Years
|
23 years
n=99 Participants
|
25 years
n=107 Participants
|
48 years
n=206 Participants
|
|
Duration of Diabetes (group)
6-8 Years
|
19 years
n=99 Participants
|
22 years
n=107 Participants
|
41 years
n=206 Participants
|
|
Duration of Diabetes (group)
≥ 9 years
|
24 years
n=99 Participants
|
13 years
n=107 Participants
|
37 years
n=206 Participants
|
|
Body Mass Index (BMI) Z Score
|
1.6 Z score
STANDARD_DEVIATION 0.4 • n=99 Participants
|
1.7 Z score
STANDARD_DEVIATION 0.3 • n=107 Participants
|
1.6 Z score
STANDARD_DEVIATION 0.3 • n=206 Participants
|
|
Body Mass Index (BMI) Percentile Group
Overweight: 85th-<95th%
|
36 participants
n=99 Participants
|
26 participants
n=107 Participants
|
62 participants
n=206 Participants
|
|
Body Mass Index (BMI) Percentile Group
Obese: ≥ 95th %
|
33 participants
n=99 Participants
|
41 participants
n=107 Participants
|
74 participants
n=206 Participants
|
|
Tanner Staging (Pubic Hair)
Stage 1
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Tanner Staging (Pubic Hair)
Stage 2
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Tanner Staging (Pubic Hair)
Stage 3
|
5 participants
n=99 Participants
|
7 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Tanner Staging (Pubic Hair)
Stage 4
|
16 participants
n=99 Participants
|
9 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Tanner Staging (Pubic Hair)
Stage 5
|
48 participants
n=99 Participants
|
49 participants
n=107 Participants
|
97 participants
n=206 Participants
|
|
Tanner Staging (Breasts/Genitals)
Stage 1
|
1 participants
n=99 Participants
|
1 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Tanner Staging (Breasts/Genitals)
Stage 2
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Tanner Staging (Breasts/Genitals)
Stage 3
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Tanner Staging (Breasts/Genitals)
Stage 4
|
12 participants
n=99 Participants
|
9 participants
n=107 Participants
|
21 participants
n=206 Participants
|
|
Tanner Staging (Breasts/Genitals)
Stage 5
|
53 participants
n=99 Participants
|
51 participants
n=107 Participants
|
104 participants
n=206 Participants
|
|
Highest Parent Educaiton Level
High school diploma, GED, or less
|
22 participants
n=99 Participants
|
20 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
Highest Parent Educaiton Level
Associate
|
10 participants
n=99 Participants
|
12 participants
n=107 Participants
|
22 participants
n=206 Participants
|
|
Highest Parent Educaiton Level
Bachelor
|
18 participants
n=99 Participants
|
15 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Highest Parent Educaiton Level
Master
|
12 participants
n=99 Participants
|
13 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Highest Parent Educaiton Level
Professional
|
5 participants
n=99 Participants
|
7 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Highest Parent Educaiton Level
Unknown / Do not want to answer
|
4 participants
n=99 Participants
|
2 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Income Category
Less than $35,000
|
5 participants
n=99 Participants
|
7 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Income Category
$35,000 to less than $50,000
|
3 participants
n=99 Participants
|
7 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Income Category
$50,000 to less than $75,000
|
10 participants
n=99 Participants
|
13 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Income Category
$75,000 to less than $100,000
|
14 participants
n=99 Participants
|
12 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Income Category
$100,000 to less than $200,000
|
5 participants
n=99 Participants
|
6 participants
n=107 Participants
|
11 participants
n=206 Participants
|
|
Income Category
Unknown / Do not want to answer
|
23 participants
n=99 Participants
|
18 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
Insurance
Private Insurance
|
53 participants
n=99 Participants
|
48 participants
n=107 Participants
|
101 participants
n=206 Participants
|
|
Insurance
Other Insurance
|
14 participants
n=99 Participants
|
15 participants
n=107 Participants
|
29 participants
n=206 Participants
|
|
Insurance
None
|
0 participants
n=99 Participants
|
2 participants
n=107 Participants
|
2 participants
n=206 Participants
|
|
Insurance
Unknown / Do not want to answer
|
4 participants
n=99 Participants
|
4 participants
n=107 Participants
|
8 participants
n=206 Participants
|
|
Severe Hypoglycemia Events Since T1D Diagnosis
None
|
52 episodes
n=99 Participants
|
52 episodes
n=107 Participants
|
104 episodes
n=206 Participants
|
|
Severe Hypoglycemia Events Since T1D Diagnosis
1-2 episodes
|
14 episodes
n=99 Participants
|
10 episodes
n=107 Participants
|
24 episodes
n=206 Participants
|
|
Severe Hypoglycemia Events Since T1D Diagnosis
3-4 episodes
|
3 episodes
n=99 Participants
|
2 episodes
n=107 Participants
|
5 episodes
n=206 Participants
|
|
Severe Hypoglycemia Events Since T1D Diagnosis
≥ 5 episodes
|
2 episodes
n=99 Participants
|
5 episodes
n=107 Participants
|
7 episodes
n=206 Participants
|
|
Diabetic Ketoacidosis Events Since T1D Diagnosis
None
|
53 episodes
n=99 Participants
|
48 episodes
n=107 Participants
|
101 episodes
n=206 Participants
|
|
Diabetic Ketoacidosis Events Since T1D Diagnosis
1-2 episodes
|
15 episodes
n=99 Participants
|
13 episodes
n=107 Participants
|
28 episodes
n=206 Participants
|
|
Diabetic Ketoacidosis Events Since T1D Diagnosis
3-4 episodes
|
2 episodes
n=99 Participants
|
6 episodes
n=107 Participants
|
8 episodes
n=206 Participants
|
|
Diabetic Ketoacidosis Events Since T1D Diagnosis
≥ 5 episodes
|
1 episodes
n=99 Participants
|
2 episodes
n=107 Participants
|
3 episodes
n=206 Participants
|
|
HbA1c Lab
|
8.8 percentage
STANDARD_DEVIATION 0.8 • n=99 Participants
|
8.8 percentage
STANDARD_DEVIATION 0.7 • n=107 Participants
|
8.8 percentage
STANDARD_DEVIATION 0.7 • n=206 Participants
|
|
HbA1c Group
< 8.5%
|
25 participants
n=99 Participants
|
24 participants
n=107 Participants
|
49 participants
n=206 Participants
|
|
HbA1c Group
8.5%-9.4%
|
32 participants
n=99 Participants
|
26 participants
n=107 Participants
|
58 participants
n=206 Participants
|
|
HbA1c Group
≥ 9.5%
|
14 participants
n=99 Participants
|
19 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
Mean Sensor Glucose
|
206 mg/dL
STANDARD_DEVIATION 35 • n=99 Participants
|
208 mg/dL
STANDARD_DEVIATION 34 • n=107 Participants
|
207 mg/dL
STANDARD_DEVIATION 34.6 • n=206 Participants
|
|
Insulin Pump Use
|
50 participants
n=99 Participants
|
49 participants
n=107 Participants
|
99 participants
n=206 Participants
|
|
Continuous Glucose Monitor Use
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Self-Monitoring of Blood Glucose per day
|
4.5 number of checks per day
STANDARD_DEVIATION 1.2 • n=99 Participants
|
4.6 number of checks per day
STANDARD_DEVIATION 1.6 • n=107 Participants
|
4.5 number of checks per day
STANDARD_DEVIATION 1.4 • n=206 Participants
|
|
Self-Monitoring of Blood Glucose group
3
|
13 participants
n=99 Participants
|
14 participants
n=107 Participants
|
27 participants
n=206 Participants
|
|
Self-Monitoring of Blood Glucose group
4-5
|
44 participants
n=99 Participants
|
43 participants
n=107 Participants
|
87 participants
n=206 Participants
|
|
Self-Monitoring of Blood Glucose group
≥ 6
|
14 participants
n=99 Participants
|
12 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Total Daily Insulin
|
1.1 unit/kg/day
STANDARD_DEVIATION 0.2 • n=99 Participants
|
1.1 unit/kg/day
STANDARD_DEVIATION 0.2 • n=107 Participants
|
1.1 unit/kg/day
STANDARD_DEVIATION 0.2 • n=206 Participants
|
|
Total Daily Insulin Group
<1.0
|
33 participants
n=99 Participants
|
26 participants
n=107 Participants
|
59 participants
n=206 Participants
|
|
Total Daily Insulin Group
1.0-1.4
|
33 participants
n=99 Participants
|
39 participants
n=107 Participants
|
72 participants
n=206 Participants
|
|
Total Daily Insulin Group
≥ 1.5
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Total Basal/Long Acting Insulin
|
0.5 unit/kg/day
STANDARD_DEVIATION 0.1 • n=99 Participants
|
0.5 unit/kg/day
STANDARD_DEVIATION 0.1 • n=107 Participants
|
0.5 unit/kg/day
STANDARD_DEVIATION 0.1 • n=206 Participants
|
|
Body Mass Index (BMI) Percentile
|
93.7 percentile
STANDARD_DEVIATION 4.1 • n=99 Participants
|
94.3 percentile
STANDARD_DEVIATION 3.8 • n=107 Participants
|
94 percentile
STANDARD_DEVIATION 3.9 • n=206 Participants
|
PRIMARY outcome
Timeframe: 0-26 weeksHemoglobin A1c is a measure of glycemic control over approximately the past 3 months
Outcome measures
| Measure |
Metformin
n=71 Participants
Metformin 2000 mg per day
Metformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
|
Oral Placebo
n=69 Participants
A central pharmacy will compound a placebo to match the metformin tablets.
The placebo product will contain the following components:
* Micosolle™, silica based excipient
* Silicified Micro Crystalline Cellulose, National Formulary
* Safflower Oil, United States Pharmacopeia
* K-30 Povidone Powder
* Magnesium Stearate, National Formulary (Vegetable source)
* Fumed Silica, National Formulary
oral placebo
|
|---|---|---|
|
Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c.
HbA1c
|
9.0 percentage
Interval 8.8 to 9.2
|
8.9 percentage
Interval 8.7 to 9.2
|
|
Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c.
Change from Baseline to 26 Weeks
|
0.2 percentage
Interval 0.0 to 0.4
|
0.2 percentage
Interval -0.1 to 0.4
|
PRIMARY outcome
Timeframe: 0-26 weeksHemoglobin A1c is a measure of glycemic control over approximately the past 3 months
Outcome measures
| Measure |
Metformin
n=71 Participants
Metformin 2000 mg per day
Metformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
|
Oral Placebo
n=69 Participants
A central pharmacy will compound a placebo to match the metformin tablets.
The placebo product will contain the following components:
* Micosolle™, silica based excipient
* Silicified Micro Crystalline Cellulose, National Formulary
* Safflower Oil, United States Pharmacopeia
* K-30 Povidone Powder
* Magnesium Stearate, National Formulary (Vegetable source)
* Fumed Silica, National Formulary
oral placebo
|
|---|---|---|
|
Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c.
HbA1c Decrease ≥0.5%
|
19 percentage of participants
|
18 percentage of participants
|
|
Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c.
HbA1c Increase ≥0.5%
|
44 percentage of participants
|
35 percentage of participants
|
|
Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c.
HbA1c <7.5%
|
3 percentage of participants
|
4 percentage of participants
|
SECONDARY outcome
Timeframe: 0-26 weeksOutcome measures
| Measure |
Metformin
n=71 Participants
Metformin 2000 mg per day
Metformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
|
Oral Placebo
n=69 Participants
A central pharmacy will compound a placebo to match the metformin tablets.
The placebo product will contain the following components:
* Micosolle™, silica based excipient
* Silicified Micro Crystalline Cellulose, National Formulary
* Safflower Oil, United States Pharmacopeia
* K-30 Povidone Powder
* Magnesium Stearate, National Formulary (Vegetable source)
* Fumed Silica, National Formulary
oral placebo
|
|---|---|---|
|
Change in Total Daily Dose of Insulin (TDI) Per kg
|
-0.1 insulin per kg
Interval -0.1 to -0.1
|
-0.0 insulin per kg
Interval -0.1 to 0.0
|
SECONDARY outcome
Timeframe: 0-26 weeksOutcome measures
| Measure |
Metformin
n=71 Participants
Metformin 2000 mg per day
Metformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
|
Oral Placebo
n=69 Participants
A central pharmacy will compound a placebo to match the metformin tablets.
The placebo product will contain the following components:
* Micosolle™, silica based excipient
* Silicified Micro Crystalline Cellulose, National Formulary
* Safflower Oil, United States Pharmacopeia
* K-30 Povidone Powder
* Magnesium Stearate, National Formulary (Vegetable source)
* Fumed Silica, National Formulary
oral placebo
|
|---|---|---|
|
Change in Body Mass Index (BMI)
|
-1 percentile
Interval -2.0 to 0.0
|
1 percentile
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 0-26 weeksOutcome measures
| Measure |
Metformin
n=71 Participants
Metformin 2000 mg per day
Metformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
|
Oral Placebo
n=69 Participants
A central pharmacy will compound a placebo to match the metformin tablets.
The placebo product will contain the following components:
* Micosolle™, silica based excipient
* Silicified Micro Crystalline Cellulose, National Formulary
* Safflower Oil, United States Pharmacopeia
* K-30 Povidone Powder
* Magnesium Stearate, National Formulary (Vegetable source)
* Fumed Silica, National Formulary
oral placebo
|
|---|---|---|
|
Change in Waist Circumference
|
-0 centimeters
Interval -2.0 to 1.0
|
1 centimeters
Interval -1.0 to 3.0
|
SECONDARY outcome
Timeframe: 0-26 weeksChange in percent body fat
Outcome measures
| Measure |
Metformin
n=71 Participants
Metformin 2000 mg per day
Metformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
|
Oral Placebo
n=69 Participants
A central pharmacy will compound a placebo to match the metformin tablets.
The placebo product will contain the following components:
* Micosolle™, silica based excipient
* Silicified Micro Crystalline Cellulose, National Formulary
* Safflower Oil, United States Pharmacopeia
* K-30 Povidone Powder
* Magnesium Stearate, National Formulary (Vegetable source)
* Fumed Silica, National Formulary
oral placebo
|
|---|---|---|
|
Change in Body Composition
|
-0 percentage of change
Interval -1.0 to 1.0
|
1 percentage of change
Interval 0.0 to 1.0
|
SECONDARY outcome
Timeframe: 0-26 weeksOutcome measures
| Measure |
Metformin
n=71 Participants
Metformin 2000 mg per day
Metformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
|
Oral Placebo
n=69 Participants
A central pharmacy will compound a placebo to match the metformin tablets.
The placebo product will contain the following components:
* Micosolle™, silica based excipient
* Silicified Micro Crystalline Cellulose, National Formulary
* Safflower Oil, United States Pharmacopeia
* K-30 Povidone Powder
* Magnesium Stearate, National Formulary (Vegetable source)
* Fumed Silica, National Formulary
oral placebo
|
|---|---|---|
|
Change in Serum Lipids
Change in LDL
|
-6 mg/dL
Interval -11.0 to 0.0
|
2 mg/dL
Interval -3.0 to 7.0
|
|
Change in Serum Lipids
Change in VLDL
|
-0 mg/dL
Interval -3.0 to 2.0
|
1 mg/dL
Interval -1.0 to 3.0
|
|
Change in Serum Lipids
Change in HDL
|
-0 mg/dL
Interval -2.0 to 2.0
|
-1 mg/dL
Interval -2.0 to 1.0
|
|
Change in Serum Lipids
Change in Triglycerides
|
4 mg/dL
Interval -5.0 to 13.0
|
6 mg/dL
Interval -5.0 to 17.0
|
|
Change in Serum Lipids
Change in Total Cholesterol
|
-5 mg/dL
Interval -11.0 to 1.0
|
3 mg/dL
Interval -3.0 to 8.0
|
SECONDARY outcome
Timeframe: 0-26 weeksOutcome measures
| Measure |
Metformin
n=71 Participants
Metformin 2000 mg per day
Metformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
|
Oral Placebo
n=69 Participants
A central pharmacy will compound a placebo to match the metformin tablets.
The placebo product will contain the following components:
* Micosolle™, silica based excipient
* Silicified Micro Crystalline Cellulose, National Formulary
* Safflower Oil, United States Pharmacopeia
* K-30 Povidone Powder
* Magnesium Stearate, National Formulary (Vegetable source)
* Fumed Silica, National Formulary
oral placebo
|
|---|---|---|
|
Change in Blood Pressure
Change in Systolic
|
0 mm Hg
Interval 0.0 to 0.0
|
-0 mm Hg
Interval 0.0 to 0.0
|
|
Change in Blood Pressure
Change in Diastolic
|
0 mm Hg
Interval 0.0 to 0.0
|
0 mm Hg
Interval 0.0 to 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-26 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 26 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-26 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-26 weeksOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-26-weeksMeasured with mixed meal tolerance test among participants with evidence of residual C-peptide on a non-fasting C-peptide at screening
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 0-26 weeksOutcome measures
Outcome data not reported
Adverse Events
Metformin
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Oral Placebo
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Metformin
n=71 participants at risk
Metformin 2000 mg per day
Metformin (glucophage): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
|
Oral Placebo
n=69 participants at risk
A central pharmacy will compound a placebo to match the metformin tablets.
The placebo product will contain the following components:
* Micosolle™, silica based excipient
* Silicified Micro Crystalline Cellulose, National Formulary
* Safflower Oil, United States Pharmacopeia
* K-30 Povidone Powder
* Magnesium Stearate, National Formulary (Vegetable source)
* Fumed Silica, National Formulary
oral placebo
|
|---|---|---|
|
Endocrine disorders
Diabetic Ketoacidosis
|
4.2%
3/71 • Number of events 3
|
4.3%
3/69 • Number of events 3
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place