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

Arm | Intervention/treatment |
---|---|
Experimental: HM11260C (0.3 mg)
Weekly administration of 0.3 mg of HMC11260C by subcutaneous injection for 12 weeks
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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
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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
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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
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Drug: Placebo
Placebo |
Active Comparator: Liraglutide
Liraglutide will be administered daily, at doses of 0.6 mg to 1.8 mg.
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Drug: liraglutide
Liraglutide is a GLP-1 agonist.
Other Name: Victoza |
- Change in baseline in glycosylated haemoglobin (HbA1c) at 12 weeks [ Time Frame: Up to 127 days ]
- Fasting plasma glucose levels (FPG) [ Time Frame: Up to 127 days ]
- 7-point glucose profile [ Time Frame: Up to day 127 ]
- Other glycaemic control parameters [ Time Frame: Up to day 127 ]
- Serum lipid profile [ Time Frame: Up to day 127 ]
- Body weight [ Time Frame: Up to day 127 ]
- Number of subjects attaining goal glycosylated haemoglobin (HbA1c) <7% [ Time Frame: Up to 127 days ]
- Assess the safety and tolerability of HM11260C [ Time Frame: Up to day 127 ]
- Assess the immunogenicity of HM11260C [ Time Frame: Up to day 127 ]

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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 |
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

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
United States, California | |
Hanmi pharmaceutical | |
CA, California, United States |
Study Director: | Hanmi Pharmaceutical | clinical4@hanmi.co.kr |
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 |
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) |
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 |