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

Phase 2

Completed

• Conditions: Type 2 Diabetes
• Interventions: Drug: Placebo; Drug: HM11260C

• Registration Number: NCT02081118
• Lead Sponsor: Hanmi Pharmaceutical Company Limited

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-02-24
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-07
• Primary Completion: 2015-03
• Study Completion: 2015-04
• Status Verified: 2016-08
• Disposition First Submitted: 2016-08-08
• Disposition First Submitted QC: 2016-08-08
• Last Update Submitted: 2016-08-08
• Disposition First Posted: 2016-08-09
• Last Update Posted: 2016-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Monthly administration of placebo by subcutaneous injection for 16 weeks
HM11260C (12 mg)	HM11260C	Monthly administration of 12 mg of HMC11260C by subcutaneous injection for 16 weeks
HM11260C (8 mg)	HM11260C	Monthly administration of 8 mg of HMC11260C by subcutaneous injection for 16 weeks
HM11260C (16 mg)	HM11260C	Monthly administration of 16 mg of HMC11260C by subcutaneous injection for 16 weeks

Primary Outcome Measures

Name	Time	Method
Change in baseline in glycosylated haemoglobin (HbA1c) at 16 weeks	Up to day 155

Secondary Outcome Measures

Name	Time	Method
Glycated albumin	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
Serum lipid profile	Up to day 155
7-point glucose profile	Up to day 155
Fasting plasma glucose levels (FPG)	Up to day 155

Trial Locations

Locations (1)

Hanmi pharmaceutical; 🇺🇸 Miami, Florida, United States