A study to compare long acting basal insulin analog to lantus in adult patients with Type 2 Diabetes Mellitus
Phase 3
Active, not recruiting
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- CTRI/2015/02/005536
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as LY2963016 as compared to LANTUS® in adults with type 2 diabetes mellitus who are on 2 or more oral antihyperglycemic medications (OAMs).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- All
- Target Recruitment
- 492
Inclusion Criteria
- Have type 2 diabetes mellitus (T2DM).
- Have been receiving 2 or more OAMs at stable doses for the 12 weeks prior to screening, with or without basal insulin.
- If currently on basal insulin, must be taking LANTUS® QD or NPH or insulin detemir either QD or twice a day for at least 90 days prior to study entry.
- Have an HbA1c ≥7.0% and ≤11.0% if insulin naïve; if previously on basal insulin, then HbA1c ≤11.0%.
- Body mass index (BMI) ≤45 kilograms per meter squared (kg/m2).
- As determined by the investigator, are capable and willing to do the following: Perform self monitored blood glucose (SMBG) Complete participant diaries as instructed Are receptive to diabetes education Comply with required study treatment and study visits.
Exclusion Criteria
- Have been on LANTUS® more than once daily within the previous 30 days.
- Have used any other insulin except the entry insulin [LANTUS®, insulin detemir, or NPH] including commercial (includes any premixed insulins) and investigational insulins within the previous 30 days.
- Have been exposed to a biosimilar insulin glargine within the previous 90 days.
- Have participated in a LY2963016 study.
- Have taken basal plus mealtime insulin (basal bolus therapy) within the last year for greater than 4 continuous weeks.
- Have used any glucagon like peptide (GLP-1) receptor agonists within the previous 90 days.
- Have used pramlintide within the previous 30 days.
- Have excessive insulin resistance at study entry (total insulin dose ≥1.5 units/kg).
- Have more than 1 episode of severe hypoglycemia within 6 months prior to screening.
- Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening.
- Have known hypersensitivity or allergy to LANTUS® or its excipients.
- Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy or have received such therapy within 4 weeks immediately preceding screening.
- Have obvious signs or symptoms, or laboratory evidence, of liver disease.
- Have one of the following concomitant diseases: significant cardiac (e.g., congestive heart failure Class III or IV) or gastrointestinal disease (e.g., significant gastroparesis).
- Have a history of renal transplantation or are currently receiving renal dialysis.
- Have had a blood transfusion or severe blood loss within 3 months prior to screening or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia.
- Participants with active cancer or personal history of cancer within the previous 5 years (with the exception of basal cell carcinoma or carcinoma in situ).
- Have a history or diagnosis of Human Immunodeficiency Virus (HIV) infection.
- Have any other condition (including known drug or alcohol abuse or psychiatric disorder including dementia) that precludes the participant from following and completing the protocol.
- Are pregnant or intend to become pregnant during the course of the study.
- Women who are breastfeeding.
- Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational product or non-approved use of a drug or device other than LY2963016, or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c) Change From Baseline to 24 Weeks in Hemoglobin A1c (HbA1c)
- Secondary Outcome Measures
Name Time Method Basal Insulin Dose Time Frame: Baseline and Week 24 Rate of Hypoglycemic Events Adjusted per 30 Days Time Frame: Baseline through Week 24 Percentage of Participants With HbA1c 7% and ≤6.5% Time Frame: Baseline and Week 24 Change from Baseline to 24 Weeks in Body Weight Time Frame: Baseline, 24 Weeks Insulin Treatment Satisfaction Questionnaire (ITSQ) Time Frame: Week 4 and Week 24 Proportion of Participants with Detectable Anti-Drug Antibodies to LY2963016 or LANTUS® Time Frame: Baseline through Week 24 Change from Baseline in 7-point Self-Monitored Blood Glucose (SMBG) Values Time Frame: Baseline and Week 24 Intra-Participant Variability in FBG Time Frame: Baseline and Week 24 Percentage of Participants with Hypoglycemic Events Time Frame: Baseline through Week 24
Trial Locations
- Locations (16)
B.J. Medical College and Civil hospital
🇮🇳Ahmadabad, GUJARAT, India
Care Hospital
🇮🇳Hyderabad, ANDHRA PRADESH, India
Dr. Mohans Diabetes Specialities Centre and MDRF
🇮🇳Chennai, TAMIL NADU, India
Eternal Heart Care Centre and Research Institute
🇮🇳Jaipur, RAJASTHAN, India
Gandhi Hospital
🇮🇳Hyderabad, ANDHRA PRADESH, India
Global Hospitals
🇮🇳Mumbai, MAHARASHTRA, India
Jivraj Mehta Smarak Health Foundation, Bakeri Medical Research Centre
🇮🇳Ahmadabad, GUJARAT, India
King George Hospital
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Lokmanya Tilak Municipal Medical College and General Hospital
🇮🇳Mumbai, MAHARASHTRA, India
Osmania General Hospital
🇮🇳Hyderabad, ANDHRA PRADESH, India
Scroll for more (6 remaining)B.J. Medical College and Civil hospital🇮🇳Ahmadabad, GUJARAT, IndiaDr Kartikeya ParmarPrincipal investigator919924643799drkartik@gmail.com