Safety Assessment of Lyxumia (Lixisenatide) and Sulfonylurea as Add-on Treatment to Basal Insulin in Uncontrolled Patients With Type 2 Diabetes Mellitus Who Elect to Fast During Ramadan (LixiRam)

International, randomized, open label study to compare the safety and efficacy of lixisenatide vs sulfonylurea on top of basal insulin treatment in Type 2 Diabetes Mellitus subjects who elect to fast during Ramadan - LixiRam

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/03/007979

Enrollment

236

Registered

2017-03-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Type 2 Diabetes Mellitus Patients Health Condition 2: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Lixisenatide: 10mcg/20mcg subcutaneous injection for 12 to 20 weeks Control Intervention1: Sulfonylurea: Sulfonylurea will be prescribed by Investigators under their commercially availa

Eligibility

Inclusion criteria

Inclusion criteria: Patients with T2DM, For complete list of inclusion criteria, please contact sponsor

Exclusion criteria

Exclusion criteria: HbA1c at screening visit 10% For complete list of exclusion criteria, please contact sponsor

Design outcomes

Primary

Measure	Time frame
Percentage (%) of patients with at least 1 documented symptomatic hypoglycemia event (plasma glucose â?¤70 mg/dL; 3.9 mmol/L) during Ramadan fast (29-30 days; from start to end of Ramadan holy month) regardless of study treatment discontinuation and/or treatment intensification.Timepoint: 29-30 days; from start to end of Ramadan holy month	—

Secondary

Measure	Time frame
â?? Mean change in body weight from baseline to pre-Ramadan visit and from baseline to post-Ramadan visitTimepoint: Baseline to post-Ramadan visit (for Mean change in HbA1c & body weight);â?? Mean change in HbA1c from baseline to pre-Ramadan visit and from baseline to post-Ramadan visitTimepoint: Baseline to post-Ramadan visit (for Mean change in HbA1c & body weight);â?? Percentage of patients with 2hPPG 180 mg/dL (10 mmol/L)(mean SMPG levels 2 hours after IFTAR during the last 14 days of RamadanTimepoint: Baseline to post-Ramadan visit (for Mean change in HbA1c & body weight);â?? Percentage of patients with FPG 130 mg/dL (7.22 mmol/L) at pre-Ramadan visitTimepoint: Baseline to post-Ramadan visit (for Mean change in HbA1c & body weight);â?? Percentage of patients with HbA1C 7% at pre-Ramadan and post-Ramadan visitsTimepoint: Baseline to post-Ramadan visit (for Mean change in HbA1c & body weight)	—

Measure

Time frame

â?? Mean change in body weight from baseline to pre-Ramadan visit and from baseline to post-Ramadan visitTimepoint: Baseline to post-Ramadan visit (for Mean change in HbA1c & body weight);â?? Mean change in HbA1c from baseline to pre-Ramadan visit and from baseline to post-Ramadan visitTimepoint: Baseline to post-Ramadan visit (for Mean change in HbA1c & body weight);â?? Percentage of patients with 2hPPG 180 mg/dL (10 mmol/L)(mean SMPG levels 2 hours after IFTAR during the last 14 days of RamadanTimepoint: Baseline to post-Ramadan visit (for Mean change in HbA1c & body weight);â?? Percentage of patients with FPG 130 mg/dL (7.22 mmol/L) at pre-Ramadan visitTimepoint: Baseline to post-Ramadan visit (for Mean change in HbA1c & body weight);â?? Percentage of patients with HbA1C 7% at pre-Ramadan and post-Ramadan visitsTimepoint: Baseline to post-Ramadan visit (for Mean change in HbA1c & body weight)

—

Countries

India, Israel, Kuwait, Lebanon, Turkey

Contacts

Public ContactSujeet Ojha

Sanofi-Synthelabo (India) Private Limited

Sujeet.Ojha@sanofi.com022-28032805

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026