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

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

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).

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Drug: HM11260C; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 209
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States
      • Hanmi pharmaceutical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HM11260C (8 mg); Monthly administration of 8 mg of HMC11260C by subcutaneous injection for 16 weeks	Drug: HM11260C; HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue); Other Names: LAPS-Exendin-4
Experimental: HM11260C (12 mg); Monthly administration of 12 mg of HMC11260C by subcutaneous injection for 16 weeks	Drug: HM11260C; HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue); Other Names: LAPS-Exendin-4
Experimental: HM11260C (16 mg); Monthly administration of 16 mg of HMC11260C by subcutaneous injection for 16 weeks	Drug: HM11260C; HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue); Other Names: LAPS-Exendin-4
Placebo Comparator: Placebo; Monthly administration of placebo by subcutaneous injection for 16 weeks	Drug: Placebo; Placebo for HM11260C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in baseline in glycosylated haemoglobin (HbA1c) at 16 weeks	Up to day 155

Secondary Outcome Measures

Outcome Measure	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

Other Outcome Measures

Outcome Measure	Time Frame
Number of Participants with Adverse Events by HM11260C	Up to day 155
Number of Participants with Immunogenicity by HM11260C	Up to day 155

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: February 24, 2014
• First Submitted That Met QC Criteria: March 5, 2014
• First Posted (Estimate): March 7, 2014

Study Record Updates

• Last Update Posted (Estimate): August 9, 2016
• Last Update Submitted That Met QC Criteria: August 8, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Incretins; Exenatide
• Other Study ID Numbers: HM-EXC-204