Glycaemic Control of Monthly 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 month 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, 16-week, Double-blind, Placebo-controlled, Parallel-group, Randomised, Multicentre Trial to Assess Effect on Glycaemic Control of Three Doses of HM11260C in Subjects With Inadequately Controlled Type 2 Diabetes Receiving a Stable Dose of Metformin

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: HM11260C
* 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 Taking a stable dose of 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 at screening 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 acute or 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 (8 mg)<br>Monthly administration of 8 mg of HMC11260C by subcutaneous injection for 16 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 (12 mg)<br>Monthly administration of 12 mg of HMC11260C by subcutaneous injection for 16 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 (16 mg)<br>Monthly administration of 16 mg of HMC11260C by subcutaneous injection for 16 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>Monthly administration of placebo by subcutaneous injection for 16 weeks | Drug: Placebo<br>* Placebo for HM11260C<br>|

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 16 weeks |  | Up to day 155 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting plasma glucose levels (FPG) |  | Up to day 155 | 
| 7-point glucose profile |  | Up to day 155 | 
| Serum lipid profile |  | Up to day 155 | 
| Body weight |  | Up to day 155 | 
| Fasting insulin |  | Up to day 155 | 
| C-peptide |  | Up to day 155 | 
| Glucagon |  | Up to day 155 | 
| Glycated albumin |  | Up to day 155 |