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

A multicenter, multinational, prospective, observational study to describe the clinical outcomes in patients with type 2 diabetes mellitus, treated with insulin glargine 300 U/mL (insulin glargine U300 before, during and after the period of Ramadan - ORION

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/02/017636
Enrollment
516
Registered
2019-02-13
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: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: NA: Observational Trial â?? Product Registry

Sponsors

Sanofi India Limited
Lead Sponsor

Eligibility

Inclusion criteria

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 physicianâ??s recommendation.

Exclusion criteria

Exclusion criteria: - Age - 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.

Design outcomes

Primary

MeasureTime frame
To assess the percentage of patients experiencing at least 1 episode of severe and/or symptomatic documented hypoglycemia with plasma glucose (PG) â?¤70 mg/dL (3.9 mmol/L) during the Pre-Ramadan, Ramadan, and Post-Ramadan periods.Timepoint: 5 months including one month of fasting in Ramadan—

Secondary

MeasureTime frame
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. To describe overall safety and tolerability of the treatment throughout the studyTimepoint: 5 months including one month of fasting in Ramadan—

Countries

Canada, Egypt, India, Indonesia, Iran (Islamic Republic of), Jordan, Kuwait, Lebanon, Pakistan, Qatar, Saudi Arabia, Turkey, United Arab Emirates

Contacts

Public ContactAshish Virkar

Sanofi India Limited

Godhuli.Chatterjee@sanofi.com912228032822

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 18, 2026