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

NCT02081118 | Completed Phase 2

• 1 other identifier: HM-EXC-204
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

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).

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

  Up to day 155

Secondary Outcomes (8)

• 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

Other Outcomes (2)

• Number of Participants with Adverse Events by HM11260C

  Up to day 155

• Number of Participants with Immunogenicity by HM11260C

  Up to day 155

Study Arms (4)

HM11260C (8 mg)

EXPERIMENTAL

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

Drug: HM11260C

HM11260C (12 mg)

EXPERIMENTAL

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

Drug: HM11260C

HM11260C (16 mg)

EXPERIMENTAL

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

Drug: HM11260C

Placebo

PLACEBO COMPARATOR

Monthly administration of placebo by subcutaneous injection for 16 weeks

Drug: Placebo

Interventions

HM11260C DRUG

HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)

Also known as: LAPS-Exendin-4

HM11260C (12 mg); HM11260C (16 mg); HM11260C (8 mg)

Placebo DRUG

Placebo for HM11260C

Placebo

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Hanmi pharmaceutical

Miami, Florida, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2014
• First Posted: March 7, 2014
• Study Start: February 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 9, 2016

Record last verified: 2016-08

Locations

US (1)