A Phase 2 Parallel Group Study in Adults with Type 2 Diabetes to evaluate Efficacy and Safety of GL0034

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sun Pharmaceutical Industries Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

6 Sep 2024 → 7 Apr 2026

Decision date (initial)

2024-07-26

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sun Pharmaceutical Industries Limited

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Safety

To investigate safety and tolerability of GL0034 with different titration algorithms over 16 weeks of treatment in people with type 2 diabetes.

Secondary objectives 2

1. To assess the effects of GL0034 on body weight, blood glucose control and other metabolic parameters over 16 weeks of treatment in people with type 2 diabetes.
2. To assess the pharmacokinetics of GL0034 over 16 weeks of treatment in people with type 2 diabetes.

Conditions and MedDRA coding

Type 2 diabetes mellitus

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Male and female patients 18 years to 70 years (both inclusive) of age on the day of signing informed consent
2. Diagnosis of Type 2 diabetes mellitus (T2DM) at least 6 months prior to informed consent
3. Have a glycated hemoglobin (HbA1c) value at screening of >= 6.5% and <=8.5% and treated with diet and exercise alone or a stable dose of metformin and/ or a SGLT-2-inhibitor for at least 3 months prior to screening
4. Have a body mass index of >=28 to <=50 kilograms per square meter (kg/m²), both are inclusive

Exclusion criteria 6

1. Were diagnosed with type 1 diabetes mellitus
2. Women who are pregnant, nursing, or who plan to become pregnant while in the trial
3. Had known allergies to GLP-1 analogs, GIP + GLP-1 analogs, glucagon, or related compounds
4. Exposure to semaglutide, or other Glucagon-like-peptide 1 receptor (GLP-1R) agonists (including combination products) within 3 months prior to screening
5. Any additional oral anti-hyperglycemic drugs beyond metformin and/ or a SGLT-2-inhibitor within 3 months prior to screening
6. Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of >5.65 mmol/L at screening and/or Day -1. If participant is on lipid-lowering therapies, doses must be stable for 30 days prior to screening

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Incidence and severity of gastrointestinal adverse events as assessed by a symptom score
2. Frequency of gastrointestinal adverse events per participant

Secondary endpoints 7

1. Change From Baseline in Glycated Hemoglobin (HbA1c)
2. Change from Baseline in Mean Daily Plasma Glucose (PG)
3. Changes in metabolic parameters (e.g. glucagon, C-peptide, insulin)
4. Change from Baseline in body weight and waist circumference
5. Change from Baseline in lipid profile (TG, TC, HDL, LDL, VLDL)
6. Pharmacokinetics of GL0034
7. Safety endpoints (e.g. adverse events others than gastrointestinal events, clinical laboratory parameters)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sun Pharmaceutical Industries Limited

Sponsor organisation

Sun Pharmaceutical Industries Limited

Address

1 Plot No 201 B, Western Express Highway, Goregaon East Western Express Highway Goregaon East

City

Mumbai

Postcode

400063

Country

India

Scientific contact point

Organisation

Sun Pharmaceutical Industries Limited

Contact name

Executive Vice-President

Public contact point

Organisation

Sun Pharmaceutical Industries Limited

Contact name

Executive Vice-President

Third parties 4

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications