Trial Outcomes & Findings for A Study of Insulin Glargine (LY2963016) in Adult Participants With Type 2 Diabetes in India (NCT NCT04153981)
NCT ID: NCT04153981
Last Updated: 2024-02-15
Results Overview
Hypoglycemic event is when the fasting blood glucose (FBG) level is ≤ 54 milligrams per deciliter (mg/dL) \[≤ 3.0 millimoles per liter (mmol/L)\].
COMPLETED
PHASE4
304 participants
Baseline to Week 24
2024-02-15
Participant Flow
Participant milestones
| Measure |
Insulin Glargine
Participants received insulin glargine once a day (QD) subcutaneously (SC) with a starting dose of 10 units. Participants self-titrated once or twice weekly until fasting blood glucose level was lowered to \<100 milligrams per deciliter (mg/dL). Dose was reduced by 4 units in case of hypoglycemia.
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|---|---|
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Overall Study
STARTED
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304
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Overall Study
Participants Who Received At Least One Dose of Study Drug
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259
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Overall Study
COMPLETED
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218
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Overall Study
NOT COMPLETED
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86
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Reasons for withdrawal
| Measure |
Insulin Glargine
Participants received insulin glargine once a day (QD) subcutaneously (SC) with a starting dose of 10 units. Participants self-titrated once or twice weekly until fasting blood glucose level was lowered to \<100 milligrams per deciliter (mg/dL). Dose was reduced by 4 units in case of hypoglycemia.
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|---|---|
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Overall Study
Death
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1
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Overall Study
Withdrawal by Subject
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24
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Overall Study
Lost to Follow-up
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1
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Overall Study
Physician Decision
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1
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Overall Study
Due to Unavailable Glucometer
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1
|
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Overall Study
Covid 19
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52
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Overall Study
Participant Dropped Out as Required Laboratory Test was Not Performed
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5
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Overall Study
Due to Low Fasting Blood Sugar Levels
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1
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Baseline Characteristics
A Study of Insulin Glargine (LY2963016) in Adult Participants With Type 2 Diabetes in India
Baseline characteristics by cohort
| Measure |
Insulin Glargine
n=259 Participants
Participants received insulin glargine QD SC with a starting dose of 10 units. Participants self-titrated once or twice weekly until fasting blood glucose level was lowered to \<100 mg/dL. Dose was reduced by 4 units in case of hypoglycemia.
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|---|---|
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Age, Continuous
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52.1 years
STANDARD_DEVIATION 11.38 • n=99 Participants
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Sex: Female, Male
Female
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93 Participants
n=99 Participants
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Sex: Female, Male
Male
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166 Participants
n=99 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Asian
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259 Participants
n=99 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Black or African American
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0 Participants
n=99 Participants
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Race (NIH/OMB)
White
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0 Participants
n=99 Participants
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Race (NIH/OMB)
More than one race
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0 Participants
n=99 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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0 Participants
n=99 Participants
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Region of Enrollment
India
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259 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Baseline to Week 24Population: All participants who received at least one dose of study drug.
Hypoglycemic event is when the fasting blood glucose (FBG) level is ≤ 54 milligrams per deciliter (mg/dL) \[≤ 3.0 millimoles per liter (mmol/L)\].
Outcome measures
| Measure |
Insulin Glargine
n=259 Participants
Participants received insulin glargine QD SC with a starting dose of 10 units. Participants self-titrated once or twice weekly until fasting blood glucose level was lowered to \<100 mg/dL. Dose was reduced by 4 units in case of hypoglycemia.
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|---|---|
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Number or Participants With Hypoglycemic Events
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10 participants
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SECONDARY outcome
Timeframe: Week 24Population: All participants who received at least one dose of study drug.
Basal Insulin Dose at Week 24.
Outcome measures
| Measure |
Insulin Glargine
n=259 Participants
Participants received insulin glargine QD SC with a starting dose of 10 units. Participants self-titrated once or twice weekly until fasting blood glucose level was lowered to \<100 mg/dL. Dose was reduced by 4 units in case of hypoglycemia.
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|---|---|
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Basal Insulin Dose
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0.30 Units per kilograms per day (U/kg/day)
Standard Deviation 0.116
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SECONDARY outcome
Timeframe: Baseline, Week 24Population: All participants who received at least one dose of study drug.
Change from baseline in body weight was evaluated. Least Square (LS) mean was calculated using generalized linear model with the analysis variable as outcome, and the baseline of the analysis variable as covariate.
Outcome measures
| Measure |
Insulin Glargine
n=259 Participants
Participants received insulin glargine QD SC with a starting dose of 10 units. Participants self-titrated once or twice weekly until fasting blood glucose level was lowered to \<100 mg/dL. Dose was reduced by 4 units in case of hypoglycemia.
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|---|---|
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Change From Baseline in Body Weight
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-0.5 kilogram (kg)
Standard Error 0.15
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SECONDARY outcome
Timeframe: Baseline, Week 12 and Week 24Population: All participants who received at least one dose of study drug.
HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured to identify average plasma glucose concentration over prolonged periods of time. LS mean was calculated using generalized linear model with the analysis variable as outcome, and the baseline of analysis variable as covariate.
Outcome measures
| Measure |
Insulin Glargine
n=259 Participants
Participants received insulin glargine QD SC with a starting dose of 10 units. Participants self-titrated once or twice weekly until fasting blood glucose level was lowered to \<100 mg/dL. Dose was reduced by 4 units in case of hypoglycemia.
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|---|---|
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Change From Baseline in Hemoglobin A1c (HbA1c)
At Week 12
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-0.641 Percentage of HbA1c
Standard Error 0.0719
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Change From Baseline in Hemoglobin A1c (HbA1c)
At Week 24
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-0.860 Percentage of HbA1c
Standard Error 0.0847
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SECONDARY outcome
Timeframe: Baseline, Week 24Population: All participants who received at least one dose of study drug.
Seven-point SMBG was completed at the following timepoints: Before Breakfast, 2 Hours After Morning Meal, Before Mid-Day Meal, 2 Hours After Mid-Day Meal, Before Evening Meal, 2 Hours After Evening Meal and at 3 AM (± 1 hour). LS mean was calculated using generalized linear model with the analysis variable as outcome, and the baseline of analysis variable as covariate.
Outcome measures
| Measure |
Insulin Glargine
n=259 Participants
Participants received insulin glargine QD SC with a starting dose of 10 units. Participants self-titrated once or twice weekly until fasting blood glucose level was lowered to \<100 mg/dL. Dose was reduced by 4 units in case of hypoglycemia.
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|---|---|
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Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values
Blood glucose concentration before breakfast
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-38.7 milligrams per deciliter (mg/dL)
Standard Error 2.12
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Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values
Blood glucose concentration 2 hours after morning meal
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-54.3 milligrams per deciliter (mg/dL)
Standard Error 2.87
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Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values
Blood glucose concentration before midday meal
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-32.9 milligrams per deciliter (mg/dL)
Standard Error 2.52
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Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values
Blood glucose concentration 2 hours after midday meal
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-43.6 milligrams per deciliter (mg/dL)
Standard Error 2.98
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Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values
Blood glucose concentration before evening meal
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-29.4 milligrams per deciliter (mg/dL)
Standard Error 2.41
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Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values
Blood glucose concentration 2 hours after evening meal
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-45.7 milligrams per deciliter (mg/dL)
Standard Error 2.97
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Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values
Blood glucose concentration at 3AM (± 1 hour)
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-32.9 milligrams per deciliter (mg/dL)
Standard Error 2.20
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SECONDARY outcome
Timeframe: Baseline (Week 4), Week 24Population: All participants who received at least one dose of study drug.
The ITSQ is a 22-item questionnaire that assesses treatment satisfaction for participants taking insulin, under 5 domains: Inconvenience of Regimen \[(IR) - 5 items\], Lifestyle Flexibility \[(LF) - 3 items\], Glycemic Control \[(GC) - 3 items\], Hypoglycemic Control \[(HC) - 5 items\], Insulin Delivery Device \[(IDD) - 6 items\]. Each Item is measured on a 7-point scale, with scores ranging for IR from 5 to 35, LF from 3 to 21, GC from 3 to 21, HC from 5 to 35, IDD from 6 to 42. Lower scores reflect better outcomes. LS mean was calculated using generalized linear model with the analysis variable as outcome, and the baseline of analysis variable as covariate. ITSQ was not evaluated at Week 0. For this outcome, Week 4 was considered as baseline.
Outcome measures
| Measure |
Insulin Glargine
n=259 Participants
Participants received insulin glargine QD SC with a starting dose of 10 units. Participants self-titrated once or twice weekly until fasting blood glucose level was lowered to \<100 mg/dL. Dose was reduced by 4 units in case of hypoglycemia.
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|---|---|
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Change From Week 4 in Insulin Treatment Satisfaction Questionnaire (ITSQ)
ITSQ IR Score
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-0.3 score on a scale
Standard Error 0.04
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Change From Week 4 in Insulin Treatment Satisfaction Questionnaire (ITSQ)
ITSQ LF Score
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-0.3 score on a scale
Standard Error 0.05
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Change From Week 4 in Insulin Treatment Satisfaction Questionnaire (ITSQ)
ITSQ GC Score
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-0.2 score on a scale
Standard Error 0.05
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Change From Week 4 in Insulin Treatment Satisfaction Questionnaire (ITSQ)
ITSQ HC Score
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-0.3 score on a scale
Standard Error 0.05
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Change From Week 4 in Insulin Treatment Satisfaction Questionnaire (ITSQ)
ITSQ IDD Score
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-0.3 score on a scale
Standard Error 0.04
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Adverse Events
Insulin Glargine
Serious adverse events
| Measure |
Insulin Glargine
n=259 participants at risk
Participants received insulin glargine QD SC with a starting dose of 10 units. Participants self-titrated once or twice weekly until fasting blood glucose level was lowered to \<100 mg/dL. Dose was reduced by 4 units in case of hypoglycemia.
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|---|---|
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General disorders
Death
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0.39%
1/259 • Number of events 1 • Up to 28 weeks
All participants who received at least one dose of study drug.
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Other adverse events
| Measure |
Insulin Glargine
n=259 participants at risk
Participants received insulin glargine QD SC with a starting dose of 10 units. Participants self-titrated once or twice weekly until fasting blood glucose level was lowered to \<100 mg/dL. Dose was reduced by 4 units in case of hypoglycemia.
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|---|---|
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Blood and lymphatic system disorders
Anaemia
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1.9%
5/259 • Number of events 5 • Up to 28 weeks
All participants who received at least one dose of study drug.
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General disorders
Pyrexia
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0.39%
1/259 • Number of events 1 • Up to 28 weeks
All participants who received at least one dose of study drug.
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Infections and infestations
Urinary tract infection
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0.39%
1/259 • Number of events 1 • Up to 28 weeks
All participants who received at least one dose of study drug.
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Metabolism and nutrition disorders
Hyperglycaemia
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0.39%
1/259 • Number of events 1 • Up to 28 weeks
All participants who received at least one dose of study drug.
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Respiratory, thoracic and mediastinal disorders
Cough
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0.39%
1/259 • Number of events 1 • Up to 28 weeks
All participants who received at least one dose of study drug.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60