A Phase 4 interventional study of Insulin Glargine in Type 2 Diabetes Mellitus, sponsored by Eli Lilly and Company. Completed at 11 sites in India. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-02-15.
Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment
The reason for this study is to see if insulin glargine is safe in participants with type 2 diabetes mellitus (T2DM) in India.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 304 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: Insulin Glargine
Administered SC
Also known as: LY2963016, Basaglar
Number or Participants With Hypoglycemic Events
Hypoglycemic event is when the fasting blood glucose (FBG) level is ≤ 54 milligrams per deciliter (mg/dL) \[≤ 3.0 millimoles per liter (mmol/L)\].
Time frame: Baseline to Week 24
Basal Insulin Dose
Basal Insulin Dose at Week 24.
Time frame: Week 24
Change From Baseline in Body Weight
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.
Time frame: Baseline, Week 24
Change From Baseline in Hemoglobin A1c (HbA1c)
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.
Time frame: Baseline, Week 12 and Week 24
Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values
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.
Time frame: Baseline, Week 24
Change From Week 4 in Insulin Treatment Satisfaction Questionnaire (ITSQ)
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.
Time frame: Baseline (Week 4), Week 24
| Milestone | Insulin Glargine |
|---|---|
| Started | 304 |
| Participants who received at least one dose of study drug | 259 |
| Completed | 218 |
| Not completed | 86 |
| Withdrew: Death | 1 |
| Withdrew: Withdrawal by subject | 24 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Physician decision | 1 |
| Withdrew: Due to unavailable glucometer | 1 |
| Withdrew: Covid 19 | 52 |
| Withdrew: Participant dropped out as required laboratory test was not performed | 5 |
| Withdrew: Due to low fasting blood sugar levels | 1 |
Hypoglycemic event is when the fasting blood glucose (FBG) level is ≤ 54 milligrams per deciliter (mg/dL) \[≤ 3.0 millimoles per liter (mmol/L)\].
| participants | Insulin Glargine |
|---|---|
| Number or Participants With Hypoglycemic Events | 10 |
Basal Insulin Dose at Week 24.
| Units per kilograms per day (U/kg/day) | Insulin Glargine |
|---|---|
| Basal Insulin Dose | 0.30 ± 0.116 |
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.
| kilogram (kg) | Insulin Glargine |
|---|---|
| Change From Baseline in Body Weight | -0.5 ± 0.15 |
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.
| Percentage of HbA1c | Insulin Glargine |
|---|---|
| At Week 12 | -0.641 ± 0.0719 |
| At Week 24 | -0.860 ± 0.0847 |
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.
| milligrams per deciliter (mg/dL) | Insulin Glargine |
|---|---|
| Blood glucose concentration before breakfast | -38.7 ± 2.12 |
| Blood glucose concentration 2 hours after morning meal | -54.3 ± 2.87 |
| Blood glucose concentration before midday meal | -32.9 ± 2.52 |
| Blood glucose concentration 2 hours after midday meal | -43.6 ± 2.98 |
| Blood glucose concentration before evening meal | -29.4 ± 2.41 |
| Blood glucose concentration 2 hours after evening meal | -45.7 ± 2.97 |
| Blood glucose concentration at 3AM (± 1 hour) | -32.9 ± 2.20 |
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.
| score on a scale | Insulin Glargine |
|---|---|
| ITSQ IR Score | -0.3 ± 0.04 |
| ITSQ LF Score | -0.3 ± 0.05 |
| ITSQ GC Score | -0.2 ± 0.05 |
| ITSQ HC Score | -0.3 ± 0.05 |
| ITSQ IDD Score | -0.3 ± 0.04 |
Collected over Up to 28 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Insulin Glargine | 1/259 (0.4%) | 1/259 (0.4%) | 8/259 (3.1%) |
| Event | Insulin Glargine |
|---|---|
| DeathGeneral disorders | 1/259 |
| Event | Insulin Glargine |
|---|---|
| AnaemiaBlood and lymphatic system disorders | 5/259 |
| PyrexiaGeneral disorders | 1/259 |
| Urinary tract infectionInfections and infestations | 1/259 |
| HyperglycaemiaMetabolism and nutrition disorders | 1/259 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/259 |
All participants who received at least one dose of study drug.
| Age, Continuous(years) | Insulin Glargine |
|---|---|
| Mean | 52.1 ± 11.38 |
| Sex: Female, Male(Participants) | Insulin Glargine |
|---|---|
| Female | 93 |
| Male | 166 |
| Race (NIH/OMB)(Participants) | Insulin Glargine |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 259 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Insulin Glargine |
|---|---|
| India | 259 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Sap, Csr
This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company