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

Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452451
• Other study ID #: HM-EXC-202
• Status: Completed
• Phase: Phase 2
• First received: October 4, 2011
• Last updated: August 8, 2016
• Start date: December 2011

Study information

• Verified date: August 2016
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

• Is a heavy tobacco user(more than 10 cigarettes a day)

• Is a heavy alcohol user

• Has a positive screen for drugs of abuse

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• HM11260C
1, 2, and 4 mg for 8 weekly subcutaneous injections for cohorts W1, W2 and W3. 8, 12 and 16 mg for 3 monthly subcutaneous injections for cohorts M1, M2 and M3
• Placebo
Placebo for 8 weekly subcutaneous injections for cohorts W1, W2 and W3. Placebo for 3 monthly subcutaneous injections for for cohorts M1, M2 and M3

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events as a measure of safety and tolerability	Number of subjects with adverse events as a measure of safety and tolerability when given different regimens to subjects in T2DM with metformin monotherapy	Up to 106 days	Yes
Secondary	The pharmacokinetics in repeat-dose	Before dosing on the first dosing day (Day 1); After the first dose: 8, 24, 48, 72, 96, 120, and 144 hours after dosing; Trough samples (ie, immediately before dosing) will be taken prior to dosing on Days 8, 22, 36, 57, 71, and 85; After the last dose (thirteenth dose) at 8, 24, 48, 72, 96, 120, and 144 hours after dosing and 7, 10, 14, 21, 28, and 35 days after dosing to define the elimination period of HM11260C	Day 1 up to Day 92	No
Secondary	The pharmacodynamics in repeat-dose	HbA1c, glycosylated albumin, fructosamine, insulin, and fasting glucose: For all cohorts: screening; Day -1; before dosing on Days 29, 57, and 85; and at follow-up.	Up to 106 days	Yes