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Efficacy and Safety of GL0034 in Overweight or Obese Adults With Type II Diabetes Mellitus

ConditionType II Diabetes Mellitus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorSun Pharmaceutical Industries Limited

About this trial

This is a phase II, randomized, double-blind, placebo-controlled study to evaluate the efficacy and tolerability of GL0034 among type II diabetes mellitus subjects who are obese or overweight with weight-related comorbidities. Subjects will be put on either one of the four treatment arms (GL0034, once a week, subcutaneous injection) or placebo arm (once a week, subcutaneous injection) following initial dose-up titration that takes up to approximately 20 weeks. The primary end point is change in HbA1c levels from baseline (Week 0) to Week 36 following treatments in all participants.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participant is willing and able to sign a written ICF or e-ICF.

Men or women ≥18 years of age at the time of signing ICF or e-ICF.

Participant was diagnosed with type II diabetes mellitus at least 180 days prior to the day of screening.

Participant has a HbA1c level of 7.0 - 10.5%, both inclusive, at the time of screening.

Disqualifiers

Participants who have a history of type I diabetes mellitus.

A self-reported change in >5% of body weight within 90 days before screening irrespective of medical records.

History of pancreatitis (acute or chronic) or >3 hypoglycemic episodes (blood glucose level <70 mg/dL or 3.9 mmol/L) within 90 days prior to screening.

Diagnosis of chronic kidney disease with estimated glomerular filtration rate <60.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GL0034 Dose Level 1

    Drug

    Dose 1, once a week

  • GL0034 Dose Level 2

    Drug

    Dose 2, once a week

  • GL0034 Dose Level 3

    Drug

    Dose 3, once a week

  • GL0034 Dose Level 4

    Drug

    Dose 4, once a week

  • GL0034 Dose Level 5

    Drug

    Dose 5, once a week

  • GL0034 Dose Level 6

    Drug

    Dose 6, once a week

  • Placebo

    Other intervention

    Placebo, once a week

Treatment groups

285 Participants
are divided into 5 treatment groups
Group A: Arm 1Experimental treatment 2 interventions
Group B: Arm 2Experimental treatment 3 interventions
Group C: Arm 3Experimental treatment 4 interventions
Group D: Arm 4Experimental treatment 6 interventions
Group E: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in HbA1c levels from baseline (Week 0) to Week 36 following treatments in all participants

Time frame
Week 36

Secondary outcomes

1

Number of participants with an HbA1c <7.0%, <6.5%, or <5.7%

Time frame
Week 36 or Week 48
2

Change in HbA1c levels from baseline (Week 0) to Week 48 following treatments in all participants

Time frame
Week 48
3

Change in HbA1c levels over time from baseline (Week 0) to Week 48 following treatments in all participants

Time frame
Week 48
4

Percent change (%) in body weight and BMI from baseline (Week 0) to Week 36, Week 48, and over time from baseline to Week 48 following treatments in all participants.

Time frame
Week 36 and Week 48

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sun Pharmaceutical Industries Limited

Lead sponsor

Source ClinicalTrials.gov
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