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

Part of paid clinical trials in CA, California.

Sponsor
Hanmi Pharmaceutical Company Limited
Study ID
NCT02057172
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • HM11260C — DRUG
    HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
  • liraglutide — DRUG
    Liraglutide is a GLP-1 agonist.
  • Placebo — DRUG
    Placebo

Study Details

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).

Key Dates

Start date
Jan 31, 2014
Status verified
Aug 2016
Primary completion
Oct 31, 2014
Completion
Dec 31, 2014

Study Design

Enrollment
254 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HM11260C (0.3 mg)
    Weekly administration of 0.3 mg of HMC11260C by subcutaneous injection for 12 weeks
  • Experimental: HM11260C (1 mg)
    Weekly administration of 1 mg of HM11260C by subcutaneous injection for 12 weeks
  • Experimental: HM11260C (2 mg)
    Weekly administration of 2 mg of HM11260C by subcutaneous injection for 12 weeks
  • Experimental: HM11260C (3 mg)
    Weekly administration of 3 mg of HM11260C by subcutaneous injection for 12 weeks
  • Experimental: HM11260C (4 mg)
    Weekly administration of 4 mg of HM11260C by subcutaneous injection for 12 weeks
  • Placebo Comparator: Placebo
    Weekly administration of placebo by subcutaneous injection for 12 weeks
  • Active Comparator: Liraglutide
    Liraglutide will be administered daily, at doses of 0.6 mg to 1.8 mg.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Hanmi pharmaceuticalCACalifornia--

Find similar trials in CA, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Hanmi pharmaceutical· CA, CA

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