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: Type 2 diabetes mellitus,

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

Brief Summary

This study is being done to meet the regulatory requirements ofconducting a Phase 4 clinical trial for Gla-300 with more than 200 Indianparticipants. This India-specific study will evaluate the safety and efficacyof insulin glargine 300 U/mL in insulin naïve participants with T2D.

At present, the most widely used basal insulin is insulin glargine 100U/ml (Gla-100), which has a well-established mode of action, and efficacy and safetyprofile. However, to improve current treatment options, a basal insulinconferring an even lower risk of hypoglycemia would be desirable.

New insulin glargine 300 U/ml (Gla-300) has been developed to optimizeglycemic control, while minimizing the risk of hypoglycemia. After subcutaneous(s.c.) injection, the pharmacokinetic and pharmacodynamic action profiles ofGla-300 were more constant and prolonged compared with those of Gla-100, as a result of a more gradualand extended release of glargine from the s.c. depot. This translates intocontinued blood glucose control beyond 24 h.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-16
• Last Update Posted: 2022-07-13

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 222

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.
• Participants who are insulin naïve on at least one oral antihyperglycemic drug (metformin, sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinide, α-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.
• 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.
• History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening visit.
• 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).
• Use of non-insulin anti-hyperglycemic drugs other than those listed in inclusion criteria.
• Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 2 weeks or more within 8 weeks prior to screening visit.
• 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.
• History of hypoglycemia unawareness.
• 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

Primary Outcome Measures

Name	Time	Method
End point:	week 24
Percentage of participants with Treatment Emergent Adverse Events (TEAEs) including serious adverse events (SAEs) and hypoglycemic episodes	week 24
Objective:	week 24
To evaluate the safety of Gla-300 in insulin naïve T2D participants uncontrolled on oral antihyperglycemic Drugs	week 24

Secondary Outcome Measures

Name	Time	Method
Objective:	To assess the efficacy of Gla-300 on glycemic control in insulin naïve T2D participants uncontrolled on oral anti-hyperglycemic drugs
End point:	Percentage of participants with at least 1 confirmed (Level 1) hypoglycemia event from baseline to Week 24.

Trial Locations

Locations (14)

Care Outpatient Centre; 🇮🇳 Hyderabad, TELANGANA, India

Dayanand Medical College and Hospital; 🇮🇳 Ludhiana, PUNJAB, India

Eternal Heart Care Centre & Research Institute; 🇮🇳 Jaipur, RAJASTHAN, India

Fortis Hospital; 🇮🇳 West, DELHI, India

Fotis Hospital Mohali; 🇮🇳 Chandigarh, CHANDIGARH, India

Government  Medical College Kozhikode; 🇮🇳 Kozhikode, KERALA, India

GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

Kovai Diabetes Speciality Center and Hospita; 🇮🇳 Coimbatore, TAMIL NADU, India

Life Care Hospital and Research Centre; 🇮🇳 Bangalore, KARNATAKA, India

Madras Diabetes Research Foundation; 🇮🇳 Chennai, TAMIL NADU, India

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Care Outpatient Centre

🇮🇳Hyderabad, TELANGANA, India

Dr Bipin Kumar Sethi

Principal investigator

04039310129

Sethibipin54@gmail.com