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| ID | Type | Description | Link |
|---|---|---|---|
| I4L-IN-ABEX | Other Identifier | Eli Lilly and Company |
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The reason for this study is to see if insulin glargine is safe in participants with type 2 diabetes mellitus (T2DM) in India.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Glargine | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Glargine | Drug | Administered SC |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)]. | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Basal Insulin Dose | Basal Insulin Dose at Week 24. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DIACARE | Ahemdabad | Gujarat | 380015 | India | ||
| Gujarat Endocrine Center |
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.
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Insulin Glargine | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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)]. | All participants who received at least one dose of study drug. | Posted | Number | participants | Baseline to Week 24 |
|
|
Up to 28 weeks
All participants who received at least one dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Insulin Glargine | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA 24 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 24 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Eli Lilly and Company | 800-545-5979 | ClinicalTrials.gov@lilly.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 4, 2019 | Jul 22, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 2, 2019 | Jul 22, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000069036 | Insulin Glargine |
| C000606659 | LY2963016 insulin glargine |
| ID | Term |
|---|---|
| D049528 | Insulin, Long-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| 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. | 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. | 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. | Baseline (Week 4), Week 24 |
| Ahmedabad |
| Gujarat |
| 380006 |
| India |
| Nirmal Hospital Private Limited | Surat | Gujarat | 395002 | India |
| Government Medical College & Sir Sayajirao General Hospital | Vadodara | Gujarat | 390001 | India |
| Sumandeep Vidhyapeeth & Dhiraj General Hospital | Vadodara | Gujarat | 391760 | India |
| Bangalore Diabetes Center | Bangalore | Karnataka | 560043 | India |
| Supe Heart & Diabetes Hospital & Research Centre | Nashik | Maharashtra | 422002 | India |
| Sir Ganga Ram Hospital | New Delhi | National Capital Territory of Delhi | 110060 | India |
| GSVM Medical College | Kanpur | Uttar Pradesh | 208002 | India |
| Popular Hospital | Varanasi | Uttar Pradesh | 221004 | India |
| Maharaja Agrasen Hospital | New Delhi | 110026 | India |
| Physician Decision |
|
| Due to Unavailable Glucometer |
|
| Covid 19 |
|
| Participant Dropped Out as Required Laboratory Test was Not Performed |
|
| Due to Low Fasting Blood Sugar Levels |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Participants |
|
|
| Secondary | Basal Insulin Dose | Basal Insulin Dose at Week 24. | All participants who received at least one dose of study drug. | Posted | Mean | Standard Deviation | Units per kilograms per day (U/kg/day) | Week 24 |
|
|
|
| Secondary | 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. | All participants who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | kilogram (kg) | Baseline, Week 24 |
|
|
|
| Secondary | 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. | All participants who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | Percentage of HbA1c | Baseline, Week 12 and Week 24 |
|
|
|
| Secondary | 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. | All participants who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | milligrams per deciliter (mg/dL) | Baseline, Week 24 |
|
|
|
| Secondary | 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. | All participants who received at least one dose of study drug. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline (Week 4), Week 24 |
|
|
|
| 1 |
| 259 |
| 1 |
| 259 |
| 8 |
| 259 |
| Pyrexia | General disorders | MedDRA 24 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 24 | Systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 24 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 24 | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
|
| Blood glucose concentration 2 hours after midday meal |
|
| Blood glucose concentration before evening meal |
|
| Blood glucose concentration 2 hours after evening meal |
|
| Blood glucose concentration at 3AM (± 1 hour) |
|
| Title | Measurements |
|---|---|
|
| ITSQ HC Score |
|
| ITSQ IDD Score |
|