Single group, multicenter phase IV clinical trial conducted in type 2 diabetes mellitus participants who are uncontrolled on oral anti-hyperglycemic drugs

Phase 4

Completed

• Conditions: Health Condition 1: E11- Type 2 diabetes mellitus

• Registration Number: CTRI/2021/07/035244
• Lead Sponsor: Sanofi India Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Participants are eligible to be included in the study only if all of the following criteria apply:

Age

I 01. Participant must be 18 years of age inclusive, at the time of signing the informed consent

Type of participant and disease characteristics

I 02. Participants with type 2 diabetes mellitus.

I 03. Participants who are insulin na�¯ve on at least one oral antihyperglycemic drug (metformin, sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinide, �±-glucosidase inhibitor) with or without glucagon-like peptide 1 receptor agonists (GLP-1 RAs) for a minimum period of 6 months prior to screening. The background non-insulin antidiabetic drug should be administered at stable dose for at least 8 weeks prior to screening

Sex

I 04. Male or female

Female participants: A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies:

Not a woman of childbearing potential (WOCBP).

OR

A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 1 week after the last dose of study intervention (i.e., until Week 27).

Informed Consent

I 05. Capable of giving signed informed consent as described in Appendix 1 of the protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Other criteria

I 06. HbA1c between 7.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening.

I 07. Median of the last 3 consecutive fasting self-monitored blood glucose (SMBG)values prior to baseline, or at least 2 fasting SMBG values in the week prior to baseline >130 mg/dL.

Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

Medical conditions

E 01. Any clinically significant abnormality identified either in medical history or during screening evaluation (e.g., physical examination, laboratory tests, electrocardiogram, vital signs) or any AEs during screening period, which in judgment of the Investigator would preclude safe completion of the study or constrains efficacy assessment.

E 02. History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening visit.

E 03. Proliferative retinopathy or maculopathy requiring treatment according to the Investigator

Prior/concomitant therapy

E 04. Treatment with any insulin including basal insulin, mixed insulin (premixes), rapid insulin, and fast-acting insulin analogues in the last 6 months before screening visit (use �10 days in relation to hospitalization or an acute illness is accepted).

E 05. Use of non-insulin anti-hyperglycemic drugs other than those listed in inclusion criteria.

E 06. Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 2 weeks or more within 8 weeks prior to screening visit.

E 07. Likelihood to require treatment prohibited by the protocol during the study

Prior/concurrent clinical study experience

E 08. Exposure to any investigational drugs in the last 4 weeks or 5 half-lives, whichever is longer, prior to screening visit or concomitant enrollment in any other clinical study involving an investigational study treatment.

Other exclusions

E 09. Any specific situation during study implementation/course that may raise ethics considerations.

E 10. History of hypoglycemia unawareness.

E 11. Hypersensitive to insulin glargine or any of the excipients

E 12. History of drug or alcohol abuse within 6 months prior to screening visit.

Additional criteria at the end of the screening period

E 13. Participants unwilling or unable to comply with study procedures as outlined in the protocol

E 14. Participants who withdraw consent during the screening (starting from signed ICF).

Study & Design

• Study Type: Interventional
• Study Design: Not specified