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

NCT02057172 | Completed Phase 2

• 1 other identifier: HM-EXC-203
• Study Type: interventional
• Target: 254
• 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 week 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

Keywords

glycaemic control; HM11260C; placebo; safety; tolerability; type 2 diabetes mellitus; efficacy; T2DM; glycated haemoglobin (HbA1c); glycosylated haemoglobin (HbA1c); Glucagon-Like Peptide-1 (GLP-1) agonists; blood sugar levels; fasting plasma glucose (FPG)

Outcome Measures

Primary Outcomes (1)

• Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks

  Up to 127 days

Secondary Outcomes (6)

• Fasting plasma glucose levels (FPG)

  Up to 127 days

• 7-point glucose profile

  Up to day 127

• Other glycaemic control parameters

  Up to day 127

• Serum lipid profile

  Up to day 127

• Body weight

  Up to day 127

Other Outcomes (2)

• Assess the safety and tolerability of HM11260C

  Up to day 127

• Assess the immunogenicity of HM11260C

  Up to day 127

Study Arms (7)

HM11260C (0.3 mg)

EXPERIMENTAL

Weekly administration of 0.3 mg of HMC11260C by subcutaneous injection for 12 weeks

Drug: HM11260C

HM11260C (1 mg)

EXPERIMENTAL

Weekly administration of 1 mg of HM11260C by subcutaneous injection for 12 weeks

Drug: HM11260C

HM11260C (2 mg)

EXPERIMENTAL

Weekly administration of 2 mg of HM11260C by subcutaneous injection for 12 weeks

Drug: HM11260C

HM11260C (3 mg)

EXPERIMENTAL

Weekly administration of 3 mg of HM11260C by subcutaneous injection for 12 weeks

Drug: HM11260C

HM11260C (4 mg)

EXPERIMENTAL

Weekly administration of 4 mg of HM11260C by subcutaneous injection for 12 weeks

Drug: HM11260C

Placebo

PLACEBO COMPARATOR

Weekly administration of placebo by subcutaneous injection for 12 weeks

Drug: Placebo

Liraglutide

ACTIVE COMPARATOR

Liraglutide will be administered daily, at doses of 0.6 mg to 1.8 mg.

Drug: liraglutide

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 (0.3 mg); HM11260C (1 mg); HM11260C (2 mg); HM11260C (3 mg); HM11260C (4 mg)

liraglutide DRUG

Liraglutide is a GLP-1 agonist.

Also known as: Victoza

Liraglutide

Placebo DRUG

Placebo

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
• Received diet and exercise therapy with or without 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
• 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 chronic pancreatitis
• A history of alcohol or drug abuse or drug addiction

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Hanmi pharmaceutical

CA, California, United States

Location

Related Publications (1)

• Rosenstock J, Sorli CH, Trautmann ME, Morales C, Wendisch U, Dailey G, Hompesch M, Choi IY, Kang J, Stewart J, Yoon KH. Once-Weekly Efpeglenatide Dose-Range Effects on Glycemic Control and Body Weight in Patients With Type 2 Diabetes on Metformin or Drug Naive, Referenced to Liraglutide. Diabetes Care. 2019 Sep;42(9):1733-1741. doi: 10.2337/dc18-2648. Epub 2019 Jul 18.

  PMID: 31320446 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Hanmi Pharmaceutical

  clinical4@hanmi.co.kr

  STUDY DIRECTOR

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: January 30, 2014
• First Posted: February 6, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 9, 2016

Record last verified: 2016-08

Locations

US (1)