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

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ClinicalTrials.gov Identifier: NCT02057172
Recruitment Status : Completed
First Posted : February 6, 2014
Last Update Posted : August 9, 2016
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Study Description
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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).

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: HM11260C Drug: liraglutide Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II, 12-week, Double-blind, Randomised, Parallel Group, Multi-centre, International Trial to Assess the Effect on Glycaemic Control of Five Doses of HM11260C Versus Placebo or Open-label Liraglutide in Subjects With Type 2 Diabetes
Study Start Date : January 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: HM11260C (0.3 mg)
Weekly administration of 0.3 mg of HMC11260C by subcutaneous injection for 12 weeks
 Drug: HM11260C
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
Other Name: LAPS-Exendin-4
Experimental: HM11260C (1 mg)
Weekly administration of 1 mg of HM11260C by subcutaneous injection for 12 weeks
 Drug: HM11260C
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
Other Name: LAPS-Exendin-4
Experimental: HM11260C (2 mg)
Weekly administration of 2 mg of HM11260C by subcutaneous injection for 12 weeks
 Drug: HM11260C
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
Other Name: LAPS-Exendin-4
Experimental: HM11260C (3 mg)
Weekly administration of 3 mg of HM11260C by subcutaneous injection for 12 weeks
 Drug: HM11260C
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
Other Name: LAPS-Exendin-4
Experimental: HM11260C (4 mg)
Weekly administration of 4 mg of HM11260C by subcutaneous injection for 12 weeks
 Drug: HM11260C
HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
Other Name: LAPS-Exendin-4
Placebo Comparator: Placebo
Weekly administration of placebo by subcutaneous injection for 12 weeks
 Drug: Placebo
Placebo
Active Comparator: Liraglutide
Liraglutide will be administered daily, at doses of 0.6 mg to 1.8 mg.
 Drug: liraglutide
Liraglutide is a GLP-1 agonist.
Other Name: Victoza


Outcome Measures
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Primary Outcome Measures :
  1. Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks [ Time Frame: Up to 127 days ]

Secondary Outcome Measures :
  1. Fasting plasma glucose levels (FPG) [ Time Frame: Up to 127 days ]
  2. 7-point glucose profile [ Time Frame: Up to day 127 ]
  3. Other glycaemic control parameters [ Time Frame: Up to day 127 ]
  4. Serum lipid profile [ Time Frame: Up to day 127 ]
  5. Body weight [ Time Frame: Up to day 127 ]
  6. Number of subjects attaining goal glycosylated haemoglobin (HbA1c) <7% [ Time Frame: Up to 127 days ]

Other Outcome Measures:
  1. Assess the safety and tolerability of HM11260C [ Time Frame: Up to day 127 ]
  2. Assess the immunogenicity of HM11260C [ Time Frame: Up to day 127 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057172


Locations
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United States, California
Hanmi pharmaceutical
CA, California, United States
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
Investigators
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Study Director: Hanmi Pharmaceutical clinical4@hanmi.co.kr
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT02057172    
Other Study ID Numbers: HM-EXC-203
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: August 9, 2016
Last Verified: August 2016
Keywords provided by Hanmi Pharmaceutical Company Limited:
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)
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liraglutide
Exenatide
 Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Obesity Agents