Observational study of Insulin Glargine 300 u/ml performed before, during and after period of Ramadan, in patients with Type 2 Diabetes Mellitus

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications,

• Registration Number: CTRI/2019/02/017636
• Lead Sponsor: Sanofi India Limited

Brief Summary

A multicenter, multinational, prospective,observational study to describe the clinical outcomes in patients with type 2diabetes mellitus, treated with insulin glargine 300 U/mL (insulin glargineU300) before, during and after the period of Ramadan. *A  patient‘s diary will be provided tothe patients in order to collect their SMPG values, as recommended by the physician, insulin doses and to report anyepisode of symptomatic hypoglycemia  andother health problems, information on days without fasting*

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-18
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 516

Inclusion Criteria

• Patient with T2DM treated with insulin glargine U300, as basal insulin for at least 8 weeks prior to inclusion in the study, and who plans to continue to be on insulin glargine U300, during the period of Ramadan.
• Patient who intends to fast for at least 15 days during Ramadan.
• Patient willing to sign written informed consent.
• Patient able and willing to perform SMPG according to physician instruction.
• Patient willing to complete study patient diary (for SMPG, insulin dose, and hypoglycemia) according to physician’s recommendation.

Exclusion Criteria

• Age <18 years old or.
• Pregnant or Breastfeeding women.
• Diabetes other than T2DM.
• Treatment with basal bolus or premix regimen, in the 6 months prior to start of treatment with insulin glargine U300.
• Use of any investigational drug within 1 month or 5 half-lives, whichever is longer, prior to selection visit.
• Known hypersensitivity/intolerance to insulin glargine U300 or any of its excipients.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess the percentage of patients experiencing at least 1 episode of severe and/or symptomatic documented hypoglycemia with plasma glucose (PG) ≤70 mg/dL (3.9 mmol/L) during the Pre-Ramadan, Ramadan, and Post-Ramadan periods.	5 months including one month of fasting in Ramadan

Secondary Outcome Measures

Name	Time	Method
To assess the incidence (percentage of patients with event) and event rate (frequency of occurrence) of symptomatic hypoglycemic episodes during the Pre-Ramadan, Ramadan, and Post-Ramadan periods.	To describe glycemic control parameters.

Trial Locations

Locations (10)

AED hospital; 🇮🇳 Hyderabad, TELANGANA, India

Center For Diabetes And Endocrine Disease; 🇮🇳 Nagar, UTTAR PRADESH, India

Delhi Diabetes Care Centre; 🇮🇳 Central, DELHI, India

Dr. Khandelwals Endocrinology Clinic; 🇮🇳 West, DELHI, India

Dr. Modis Clinic; 🇮🇳 Hyderabad, TELANGANA, India

Esani Diabetes and Multispeciality Centre; 🇮🇳 Hyderabad, TELANGANA, India

F S Endocrine Centre; 🇮🇳 Hyderabad, TELANGANA, India

Lifespan Diabetes and Metabolic Clinics; 🇮🇳 Hyderabad, TELANGANA, India

Sakshi Diabetic & Medical Centre; 🇮🇳 Hyderabad, TELANGANA, India

Yalamanchi Diabetes Specialities Center; 🇮🇳 Krishna, ANDHRA PRADESH, India

AED hospital

🇮🇳Hyderabad, TELANGANA, India

Dr Ravi K Muppidi

Principal investigator

9885554414

ravimuppidi@gmail.com