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Safety, Tolerability, Pharmacokinetics,Pharmacodynamics Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Safety, Tolerability, Pharmacokinetics,Pharmacodynamics Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus

A Double-Masked, Randomized, Placebo-Controlled, Multiple Ascending Dose Phase 2 Study to Determine the Tolerability, Pharmacokinetics, and Pharmacodynamics of the GLP 1 Agonist HM11260C in Adult Subjects With Type 2 Diabetes Mellitus on Stable Metformin Monotherapy

NCT01452451•Hanmi Pharmaceutical Company Limited

View on ClinicalTrials.gov

Summary

The purpose of this study is to investigate the safety and tolerability of repeated doses of HM11260C when given different regimens in subjects with type 2 diabetes mellitus (T2DM) on stable metformin monotherapy.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Is male or female and 18 to 65 years of age, inclusive, at screening
•Has a history of T2DM and a stable dose of metformin
•Has HbA1c levels at screening between 7% and 10%

Exclusion Criteria

•Is pregnant or lactating
•Has type 1 diabetes
•Has a significant change in body weight in the 3 months before screening
•Has a fasting plasma glucose level greater than 240 mg/dL (13.3 mmol/L) at screening
•Has an estimated glomerular filtration rate rate \<75 mL/min/1.73 m2 or has ≥75 mL/min/1.73 m2 \<estimated glomerular filtration rate \<90 mL/min/1.73 m2 with a urine albumin to urine creatinine ratio \>30 mg/g.
•Has alanine aminotransferase or aspartate aminotransferase values \>2.0 × upper limit of normal or total bilirubin \>1.5 × upper limit of normal unless the subject has a known history of Gilbert's syndrome
•Has fasting serum triglycerides \>400 mg/dL (\>4.52 mmol/L) or \>250 mg/dL (\>2.85 mmol/L) if not on stable lipid-lowering therapy for at least 4 weeks prior to screening, or has calcitonin ≥50 ng/L. Subjects with a history of Fredrickson's Type I, IV or V hyperlipidemia will be excluded.
•Has any history of GI intolerance, chronic diarrhea, inflammatory bowel disease, partial bypass or gastric banding
•Has any acute illness within 5 days before first study drug administration
•Has elevated amylase, ongoing cholelithiasis, cholecystitis at screening, or history of pancreatitis
+3 more criteria

Locations (1)

Ohio City, Ohio, United States

Key Dates

Start Date

December 1, 2011

Primary Completion Date

June 1, 2013

Last Updated

August 9, 2016

Enrollment

ACTUAL participants

Conditions

Diabetes Mellitus

Interventions

HM11260C

DRUG

Placebo

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

View study

RECRUITING

Genetic Studies of Insulin and Diabetes

NCT00001987

Diabetes MellitusSevere Insulin Resistance

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 9, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety, Tolerability, Pharmacokinetics,Pharmacodynamics Study of LAPS-Exendin in Subjects of Type 2 Diabetes Mellitus

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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