Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered once a week under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM).

Official Title
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A Phase II, 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, International Trial to Assess the Effect on Glycaemic Control of Five Doses of HM11260C Versus Placebo or Open-label Liraglutide in Subjects With Type 2 Diabetes

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: HM11260C
* Drug: liraglutide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ages eligible for study : 18 years to 74 years Genders eligible for study : Male and Female Diagnosed with T2DM Received diet and exercise therapy with or without metformin monotherapy HbA1c levels of between ≥ 7.0% and ≤ 10.0% Females of childbearing potential who are not pregnant and agree to use a reliable method of birth control Written informed consent must be obtained Exclusion Criteria: Pregnant or nursing (lactating) women Diagnosis of type 1 diabetes mellitus Uncontrolled diabetes defined as a FPG level of > 240 mg/dL A significant change in body weight in the 3 months before screening Any history of GI intolerance Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC Known history of chronic pancreatitis A history of alcohol or drug abuse or drug addiction

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HM11260C (0.3 mg)<br>Weekly administration of 0.3 mg of HMC11260C by subcutaneous injection for 12 weeks | Drug: HM11260C<br>* HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)<br>* Other names: LAPS-Exendin-4;|
| Experimental: HM11260C (1 mg)<br>Weekly administration of 1 mg of HM11260C by subcutaneous injection for 12 weeks | Drug: HM11260C<br>* HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)<br>* Other names: LAPS-Exendin-4;|
| Experimental: HM11260C (2 mg)<br>Weekly administration of 2 mg of HM11260C by subcutaneous injection for 12 weeks | Drug: HM11260C<br>* HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)<br>* Other names: LAPS-Exendin-4;|
| Experimental: HM11260C (3 mg)<br>Weekly administration of 3 mg of HM11260C by subcutaneous injection for 12 weeks | Drug: HM11260C<br>* HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)<br>* Other names: LAPS-Exendin-4;|
| Experimental: HM11260C (4 mg)<br>Weekly administration of 4 mg of HM11260C by subcutaneous injection for 12 weeks | Drug: HM11260C<br>* HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)<br>* Other names: LAPS-Exendin-4;|
| Placebo Comparator: Placebo<br>Weekly administration of placebo by subcutaneous injection for 12 weeks | Drug: Placebo<br>* Placebo<br>|
| Active Comparator: Liraglutide<br>Liraglutide will be administered daily, at doses of 0.6 mg to 1.8 mg. | Drug: liraglutide<br>* Liraglutide is a GLP-1 agonist.<br>* Other names: Victoza;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks |  | Up to 127 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose levels (FPG) |  | Up to 127 days | 
| 7-point glucose profile |  | Up to day 127 | 
| Other glycaemic control parameters |  | Up to day 127 | 
| Serum lipid profile |  | Up to day 127 | 
| Body weight |  | Up to day 127 | 
| Number of subjects attaining goal glycosylated haemoglobin (HbA1c) <7% |  | Up to 127 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glycaemic control, HM11260C, placebo, safety, tolerability, type 2 diabetes mellitus, efficacy, T2DM, glycated haemoglobin (HbA1c), glycosylated haemoglobin (HbA1c), Glucagon-Like Peptide-1 (GLP-1) agonists, blood sugar levels, fasting plasma glucose (FPG)