Trial Outcomes & Findings for Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Sitagliptin (REMIT-Sita) (NCT NCT02623998)
NCT ID: NCT02623998
Last Updated: 2022-03-25
Results Overview
Hyperglycemia relapse for primary outcome was defined as any one of: 1. Capillary glucose \>10 mmol/L on \>/=50% of readings over 1 week; 2. HbA1C \>/=6.5%; 3. use of diabetes drugs; 4. fasting plasma glucose \>/= 7.0 mmol/L; 5. 2-hour postprandial plasma glucose \>/=11.1 mmol/L on an oral glucose tolerance test.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
102 participants
Primary outcome timeframe
64 weeks of follow-up
Results posted on
2022-03-25
Participant Flow
Participant milestones
| Measure |
Intervention
Drug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy
insulin glargine: Dose is titrated to achieve fasting normoglycemia
sitagliptin/metformin: Dose is titrated to 50/1000 mg bid or maximal tolerated dose
lifestyle therapy: Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
|
Standard Care
Standard glycemic care as informed by the current clinical practice guidelines
|
|---|---|---|
|
Overall Study
STARTED
|
50
|
52
|
|
Overall Study
COMPLETED
|
48
|
51
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Remission Evaluation of a Metabolic Intervention in Type 2 Diabetes With Sitagliptin (REMIT-Sita)
Baseline characteristics by cohort
| Measure |
Intervention
n=50 Participants
Drug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy
insulin glargine: Dose is titrated to achieve fasting normoglycemia
sitagliptin/metformin: Dose is titrated to 50/1000 mg bid or maximal tolerated dose
lifestyle therapy: Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
|
Standard Care
n=52 Participants
Standard glycemic care as informed by the current clinical practice guidelines
|
Total
n=102 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.4 years
STANDARD_DEVIATION 8.7 • n=99 Participants
|
54.7 years
STANDARD_DEVIATION 9.3 • n=107 Participants
|
55.5 years
STANDARD_DEVIATION 9.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=99 Participants
|
32 Participants
n=107 Participants
|
64 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
42 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Non-Caucasian
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
50 participants
n=99 Participants
|
52 participants
n=107 Participants
|
102 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 64 weeks of follow-upHyperglycemia relapse for primary outcome was defined as any one of: 1. Capillary glucose \>10 mmol/L on \>/=50% of readings over 1 week; 2. HbA1C \>/=6.5%; 3. use of diabetes drugs; 4. fasting plasma glucose \>/= 7.0 mmol/L; 5. 2-hour postprandial plasma glucose \>/=11.1 mmol/L on an oral glucose tolerance test.
Outcome measures
| Measure |
Intervention
n=50 Participants
Drug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy
insulin glargine: Dose is titrated to achieve fasting normoglycemia
sitagliptin/metformin: Dose is titrated to 50/1000 mg bid or maximal tolerated dose
lifestyle therapy: Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
|
Standard Care
n=52 Participants
Standard glycemic care as informed by the current clinical practice guidelines
|
|---|---|---|
|
Number of Participants With Hyperglycemia Relapse in the Experimental Group Compared to the Control Group
|
41 Participants
|
48 Participants
|
PRIMARY outcome
Timeframe: 64 weeks of follow-upOutcome measures
| Measure |
Intervention
n=50 Participants
Drug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy
insulin glargine: Dose is titrated to achieve fasting normoglycemia
sitagliptin/metformin: Dose is titrated to 50/1000 mg bid or maximal tolerated dose
lifestyle therapy: Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
|
Standard Care
n=52 Participants
Standard glycemic care as informed by the current clinical practice guidelines
|
|---|---|---|
|
Number of Participants With Severe Hypoglycemic Episodes
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24 weeks after randomizationDiabetes remission is defined as absence of hyperglycemia relapse
Outcome measures
| Measure |
Intervention
n=50 Participants
Drug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy
insulin glargine: Dose is titrated to achieve fasting normoglycemia
sitagliptin/metformin: Dose is titrated to 50/1000 mg bid or maximal tolerated dose
lifestyle therapy: Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
|
Standard Care
n=52 Participants
Standard glycemic care as informed by the current clinical practice guidelines
|
|---|---|---|
|
Number of Participants Achieving Drug-free Diabetes Remission
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 weeks after randomizationNormal glucose tolerance is defined as a FPG\<6.1 mmol/L and a 2-hour plasma glucose \<7.8 mmol/L on a 75 g oral glucose tolerance test
Outcome measures
| Measure |
Intervention
n=50 Participants
Drug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy
insulin glargine: Dose is titrated to achieve fasting normoglycemia
sitagliptin/metformin: Dose is titrated to 50/1000 mg bid or maximal tolerated dose
lifestyle therapy: Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
|
Standard Care
n=52 Participants
Standard glycemic care as informed by the current clinical practice guidelines
|
|---|---|---|
|
Number of Participants With Drug-free Normal Glucose Tolerance
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks after randomizationOutcome measures
| Measure |
Intervention
n=50 Participants
Drug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy
insulin glargine: Dose is titrated to achieve fasting normoglycemia
sitagliptin/metformin: Dose is titrated to 50/1000 mg bid or maximal tolerated dose
lifestyle therapy: Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
|
Standard Care
n=52 Participants
Standard glycemic care as informed by the current clinical practice guidelines
|
|---|---|---|
|
Percent Change in Weight
|
-2.1 % change
Standard Deviation 2.5
|
-1.4 % change
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline and 12 weeks after randomizationOutcome measures
| Measure |
Intervention
n=50 Participants
Drug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy
insulin glargine: Dose is titrated to achieve fasting normoglycemia
sitagliptin/metformin: Dose is titrated to 50/1000 mg bid or maximal tolerated dose
lifestyle therapy: Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
|
Standard Care
n=52 Participants
Standard glycemic care as informed by the current clinical practice guidelines
|
|---|---|---|
|
Change in Waist Circumference
|
-2.3 cm
Standard Deviation 3.5
|
-1.8 cm
Standard Deviation 4.8
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 9 other events
Deaths: 1 deaths
Standard Care
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention
n=50 participants at risk
Drug: insulin glargine - sc injection Drug: sitagliptin/metformin - oral administration Behavioral: lifestyle therapy
insulin glargine: Dose is titrated to achieve fasting normoglycemia
sitagliptin/metformin: Dose is titrated to 50/1000 mg bid or maximal tolerated dose
lifestyle therapy: Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
|
Standard Care
n=52 participants at risk
Standard glycemic care as informed by the current clinical practice guidelines
|
|---|---|---|
|
Cardiac disorders
Atrial flutter
|
2.0%
1/50 • Number of events 1 • 64 weeks
|
0.00%
0/52 • 64 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint pain
|
6.0%
3/50 • Number of events 4 • 64 weeks
|
0.00%
0/52 • 64 weeks
|
|
Psychiatric disorders
Anxiety/depression
|
2.0%
1/50 • Number of events 1 • 64 weeks
|
1.9%
1/52 • Number of events 1 • 64 weeks
|
|
Cardiac disorders
Vasovagal syncope
|
2.0%
1/50 • Number of events 1 • 64 weeks
|
0.00%
0/52 • 64 weeks
|
|
Infections and infestations
Infection
|
2.0%
1/50 • Number of events 1 • 64 weeks
|
1.9%
1/52 • Number of events 2 • 64 weeks
|
|
Eye disorders
Allergic conjunctivitis
|
2.0%
1/50 • Number of events 1 • 64 weeks
|
0.00%
0/52 • 64 weeks
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
0.00%
0/50 • 64 weeks
|
1.9%
1/52 • Number of events 1 • 64 weeks
|
|
Surgical and medical procedures
Elective surgery
|
0.00%
0/50 • 64 weeks
|
1.9%
1/52 • Number of events 1 • 64 weeks
|
|
Injury, poisoning and procedural complications
Superficial skin injury
|
2.0%
1/50 • Number of events 1 • 64 weeks
|
0.00%
0/52 • 64 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place