A Phase 1b Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus
Status unconfirmed · Phase 1 · Has a placebo group
Conditions studied: Diabetes Mellitus
In brief
A Phase 1b, Exploratory, Randomized, Partially Single Blinded, Placebo and Open Label Controlled, Parallel Group Study to Assess the Effects of HM11260C and an Active Comparator on Gastric Emptying and Beta-Cell Response in Subjects with Type 2 Diabetes Mellitus
Key facts
- Study ID
- NCT02059564
- Run by
- Hanmi Pharmaceutical Company Limited
- People needed
- 44
- Starts
- 2013-12-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2014-02-11
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Adults ≥18 to ≤ 70 years of age at the time of the Screening Visit
- History of type 2 diabetes
- Body mass index (BMI) ≥18 to ≤45 kg/m2 at the Screening Visit
- Use of approved methods of contraception
- Ability to provide written informed consent
You may not qualify if…
- Type 1 diabetes
- Significant acute diabetic proliferative retinopathy or severe neuropathy
- Systolic blood pressure >160 mm Hg and/or diastolic blood pressure >100 mm Hg at screening
- Pregnant or lactating women
- Participation in an investigational study within 30 days prior to randomization
- History of any major surgery within 6 months prior to Screening
- History of any serious adverse reaction or hypersensitivity to any of the product components.
- History of renal disease or significantly abnormal kidney function tests at Screening
- History of hepatic disease or significantly abnormal liver function tests
- History of any active infection within 30 days prior to Randomization
- Presence of clinically significant physical, laboratory, or ECG findings at Screening that, in the opinion of the Investigator, may interfere with any aspect of study conduct or interpretation of results
- Concurrent conditions that could interfere with safety and/or tolerability measurements per the investigator
- Donation or loss of >500 mL of blood or blood product within 56 days of Randomization
Where it is running
- Hanmi — California City, California, United States (enrolling)
Full record on ClinicalTrials.gov
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