24-week Treatment With Lixisenatide in Type 2 Diabetes Insufficiently Controlled With Metformin and Insulin Glargine

Phase 3

Completed

• Conditions: Health Condition 1: null- In patients with Type 2 diabetes insufficiently controlled with insulin glargine and metformin.Health Condition 2: E119- Type 2 diabetes mellitus without complications

• Registration Number: CTRI/2009/091/000807
• Lead Sponsor: SanofiSynthelabo India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 450

Inclusion Criteria

Patients with type 2 diabetes mellitus, as defined by WHO (1), diagnosed for at least 1 year

at the time of screening visit, insufficiently controlled with metformin at a stable dose of at

least 1.5 g/day for at least 3 months prior to the screening visit. In addition to metformin,

patients may receive sulfonylureas (that must be discontinued at visit 1) and/or

thiazolidinediones (that can be continued).

Exclusion Criteria

At screening:

- Pregnancy or lactation
- Women of childbearing potential with no effective contraceptive method.
- Type 1 diabetes mellitus
- Metformin not at a stable dose of at least 1.5 g/day for at least 3 months prior to the screening visit.
- Use of oral or injectable antidiabetic or hypoglycemic agents other than metformin, sulfonylurea and thiazolidinediones within 3 months prior to the time of screening, use of weight loss drugs if not at a stable dose for at least 3 months prior to the screening visit.
- History of hypoglycemia unawareness.
- History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy, stomach/gastric surgery, inflammatory bowel disease
- History of metabolic acidosis, including diabetic ketoacidosis within 1 year prior to screening
- Hemoglobinopathy or hemolytic anemia, blood or plasma products transfusion within 3 months prior to the time of screening
- Within the last 6 months prior to screening: history of myocardial infarction, stroke, or heart failure requiring hospitalization
- Known history of drug or alcohol abuse within 6 months prior to the time of screening
- Uncontrolled or inadequately controlled hypertension at the time of screening with a resting systolic or diastolic blood pressure > 180 mmHg or > 110 mmHg, respectively
- Use of systemic glucocorticoids (excluding topical application or inhaled forms) for one week or more within 3 months prior to the time of screening
- Use of any investigational drug within 3 months prior to screening
- Renal impairment defined with serum creatinine > 1.4 mg/dL in women and > 1.5 mg/dL in men
- History of hypersensitivity to insulin glargine or to any of the excipients
- Clinically relevant history of gastrointestinal disease associated with prolonged nausea and vomiting, including (but not limited to): gastroparesis, unstable (i.e worsening) and not controlled (i.e prolonged nausea and vomiting) gastroesophageal reflux disease requiring medical treatment, within 6 months prior to the time of screening
- Any previous treatment with lixisenatide (e.g. participation in a previous study with lixisenatide)
- Allergic reaction to any GLP-1 receptor agonist in the past (e.g. exenatide, liraglutide) or to metacresol.

Additional exclusion criteria during or at the end of the run-in phase before randomization :

- Informed consent withdrawal (patient who is not willing to continue or fails to return)
- Mean fasting SMPG calculated from the self-measurements for the 7 days prior to visit 12 (week -1) is > 126 mg/dl (7.0 mmol/l)
- HbA1c measured at visit 12 (week -1) is < 7% or > 9 %,
- Amylase and/or lipase > 3 times the upper limit of the normal laboratory range at visit 12 (week -1)

Study & Design

• Study Type: Interventional
• Study Design: Not specified