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

Primary Purpose

Type 2 Diabetes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
HM11260C
Placebo
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hanmi pharmaceutical

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

HM11260C (8 mg)

HM11260C (12 mg)

HM11260C (16 mg)

Placebo

Arm Description

Monthly administration of 8 mg of HMC11260C by subcutaneous injection for 16 weeks

Monthly administration of 12 mg of HMC11260C by subcutaneous injection for 16 weeks

Monthly administration of 16 mg of HMC11260C by subcutaneous injection for 16 weeks

Monthly administration of placebo by subcutaneous injection for 16 weeks

Outcomes

Primary Outcome Measures

Change in baseline in glycosylated haemoglobin (HbA1c) at 16 weeks

Secondary Outcome Measures

Fasting plasma glucose levels (FPG)
7-point glucose profile
Serum lipid profile
Body weight
Fasting insulin
C-peptide
Glucagon
Glycated albumin

Full Information

First Posted
February 24, 2014
Last Updated
August 8, 2016
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT02081118
Brief Title
Glycaemic Control of Monthly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HM11260C (8 mg)
Arm Type
Experimental
Arm Description
Monthly administration of 8 mg of HMC11260C by subcutaneous injection for 16 weeks
Arm Title
HM11260C (12 mg)
Arm Type
Experimental
Arm Description
Monthly administration of 12 mg of HMC11260C by subcutaneous injection for 16 weeks
Arm Title
HM11260C (16 mg)
Arm Type
Experimental
Arm Description
Monthly administration of 16 mg of HMC11260C by subcutaneous injection for 16 weeks
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Monthly administration of placebo by subcutaneous injection for 16 weeks
Intervention Type
Drug
Intervention Name(s)
HM11260C
Other Intervention Name(s)
LAPS-Exendin-4
Intervention Description
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo for HM11260C
Primary Outcome Measure Information:
Title
Change in baseline in glycosylated haemoglobin (HbA1c) at 16 weeks
Time Frame
Up to day 155
Secondary Outcome Measure Information:
Title
Fasting plasma glucose levels (FPG)
Time Frame
Up to day 155
Title
7-point glucose profile
Time Frame
Up to day 155
Title
Serum lipid profile
Time Frame
Up to day 155
Title
Body weight
Time Frame
Up to day 155
Title
Fasting insulin
Time Frame
Up to day 155
Title
C-peptide
Time Frame
Up to day 155
Title
Glucagon
Time Frame
Up to day 155
Title
Glycated albumin
Time Frame
Up to day 155
Other Pre-specified Outcome Measures:
Title
Number of Participants with Adverse Events by HM11260C
Time Frame
Up to day 155
Title
Number of Participants with Immunogenicity by HM11260C
Time Frame
Up to day 155

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Hanmi pharmaceutical
City
Miami
State/Province
Florida
Country
United States

12. IPD Sharing Statement

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

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