A Study of Insulin Glargine (LY2963016) in Adult Participants With Type 2 Diabetes in India
- Registration Number
- NCT04153981
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The reason for this study is to see if insulin glargine is safe in participants with type 2 diabetes mellitus (T2DM) in India.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 304
- Have T2DM based on the disease diagnostic criteria from the World Health Organization (WHO) classification for at least 6 months before screening.
- Have been receiving glucagon-like peptide-1 receptor agonist (GLP-1 RA) or ≥2 oral antihyperglycemic medication (OAMs) at stable doses for 90 days prior to screening.
- Have an HbA1c level ≥7.0% and <11.0%.
- Have never been treated with insulins except for short term treatment of acute conditions up to a maximum of 14 days.
- Have any form of diabetes other than T2DM.
- Have hypersensitivity to the active substance of LY2963016 or to any of the excipients.
- Have any clinically significant disorder, other than T2DM, that in the investigator's opinion, would preclude participation in the trial.
- Are receiving systemic glucocorticosteroids therapy or have excessive insulin resistance (total insulin dose >2 units per kilogram).
- Have a history or diagnosis of human immunodeficiency virus infection, hepatitis B and C.
- Have comorbidities of unstable angina, cardiac failure (Stage III or IV as per New York Heart Association guidelines) or renal failure (estimated glomerular filtration rate <30 milliliters/minute/meter squared).
- Are pregnant or intend to become pregnant during the course of the study; or are sexually active women of child-bearing potential not actively practicing birth control by a medically acceptable method as determined by the investigator.
- Is a woman who is breastfeeding.
- Have participated within the last 30 days in a clinical trial involving an investigational product other than the LY2963016. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed.
- Have previously completed or withdrawn from this study or any other study investigating LY2963016. This exclusion criterion does not apply to participants who are rescreened prior to baseline visit.
- Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
- Are unwilling or unable to comply with the use of a glucometer.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Insulin Glargine 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.
- Primary Outcome Measures
Name Time Method Number or Participants With Hypoglycemic Events Baseline to Week 24 Hypoglycemic event is when the fasting blood glucose (FBG) level is ≤ 54 milligrams per deciliter (mg/dL) \[≤ 3.0 millimoles per liter (mmol/L)\].
- Secondary Outcome Measures
Name Time Method Change From Week 4 in Insulin Treatment Satisfaction Questionnaire (ITSQ) Baseline (Week 4), Week 24 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.
Basal Insulin Dose Week 24 Basal Insulin Dose at Week 24.
Change From Baseline in Body Weight Baseline, Week 24 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.
Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 12 and Week 24 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.
Change From Baseline in 7-Point Self-Monitoring Blood Glucose (SMBG) Values Baseline, Week 24 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.
Trial Locations
- Locations (11)
Government Medical College & Sir Sayajirao General Hospital
🇮🇳Vadodara, Gujarat, India
Gujarat Endocrine Center
🇮🇳Ahmedabad, Gujarat, India
DIACARE
🇮🇳Ahemdabad, Gujarat, India
Nirmal Hospital Private Limited
🇮🇳Surat, Gujarat, India
Sumandeep Vidhyapeeth & Dhiraj General Hospital
🇮🇳Vadodara, Gujarat, India
Bangalore Diabetes Center
🇮🇳Bangalore, Karnataka, India
Supe Heart & Diabetes Hospital & Research Centre
🇮🇳Nasik, Maharashtra, India
Sir Ganga Ram Hospital
🇮🇳New Delhi, Delhi, India
Popular Hospital
🇮🇳Varanasi, Uttar Pradesh, India
Maharaja Agrasen Hospital
🇮🇳New Delhi, India
GSVM Medical College
🇮🇳Kanpur, Uttar Pradesh, India