AMG 151 Amgen Protocol Number 20100761

Phase 2

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: Placebo; Drug: AMG 151; Drug: Metformin

• Registration Number: NCT01464437
• Lead Sponsor: Amgen

Brief Summary

This is a phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel group, fixed dose study. AMG 151 will be evaluated in subjects with type 2 diabetes treated with metformin for at least 3 months prior to randomization.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-10-14
• Study First Submitted QC: 2011-11-01
• Study First Posted: 2011-11-03
• Primary Completion: 2012-10
• Study Completion: 2012-12
• Disposition First Submitted: 2013-11-06
• Disposition First Submitted QC: 2013-11-06
• Disposition First Posted: 2013-11-28
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 236

Inclusion Criteria

• Age 18 to 75 years, inclusive
• Diagnosis of type 2 diabetes mellitus
• HbA1c levels 7.5% to 11.0%, inclusive, at screening
• Fasting C-peptide levels ≥ 0.2 nmol/L at screening
• BMI ≥ 25 to < 45 kg/m2 at screening
• Treated with metformin monotherapy for at least 3 months prior to randomization; the metformin dose must be ≥ 850 mg daily for at least 2 months immediately prior to randomization
• If a subject is being treated for hyperlipidemia or hypertension they should be on stable medication for 30 days before randomization
• Subject has provided informed consent.

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Exclusion Criteria

• History of type 1 diabetes
• History of significant weight gain or loss (> 10%) during the 4 weeks before randomization
• Use of any weight loss medication (over the counter or prescription) within 60 days of randomization
• Use of any oral or injectable anti-hyperglycemic medication (other than metformin) within 3 months prior to randomization
• Use of chronic and/or continuous insulin administration for > 15 days in an outpatient setting to achieve and maintain glycemic control prior to randomization
• Have had 2 or more emergency room visits or hospitalizations due to poor glucose control in the past 6 months
• Have had more than 1 episode of severe hypoglycemia within 6 months prior to entry into the study, or currently diagnosed as having hypoglycemia unawareness
• Evidence of active infections that can interfere with the study
• Presence of clinically significant organ system disease that is not stabilized or may interfere with the study
• Currently receiving immunosuppressive therapy
• History of positive HIV, chronic hepatitis B or C, or cirrhosis
• Have symptomatic congestive heart failure or a history of myocardial infarction, unstable angina, or decompensated congestive heart failure or stroke in the past 6 months prior to screening.
• History of gastric surgery, vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption
• Any finding on the screening ECG that in the opinion of the investigator requires further cardiovascular evaluation
• Poorly controlled hypertension defined as diastolic pressure > 100 mm Hg or systolic pressure > 160 mm Hg (assessed on two separate occasions during the screening period)
• Malignancy (other than resected cutaneous basal or cutaneous squamous cell carcinoma, or treated in situ cervical cancer considered cured) within 5 years of screening visit (if a malignancy occurred > 5 years ago, subject is eligible with documentation of disease-free state since treatment)
• Use of known inhibitors or inducers of CYP3A4 are not permitted 30 days prior to randomization

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMG 151 - Arm 6	AMG 151	AMG 151 - Arm 6
Placebo Arm	Placebo	AMG 151 Placebo Arm
AMG 151 - Arm 1	AMG 151	AMG 151 - Arm 1
AMG 151 - Arm 1	Metformin	AMG 151 - Arm 1
AMG 151 - Arm 2	Metformin	AMG 151 - Arm 2
AMG 151 - Arm 2	AMG 151	AMG 151 - Arm 2
AMG 151 - Arm 3	Metformin	AMG 151 - Arm 3
AMG 151 - Arm 3	AMG 151	AMG 151 - Arm 3
AMG 151 - Arm 4	Metformin	AMG 151 - Arm 4
AMG 151 - Arm 4	AMG 151	AMG 151 - Arm 4
AMG 151 - Arm 5	Metformin	AMG 151 - Arm 5
AMG 151 - Arm 5	AMG 151	AMG 151 - Arm 5
AMG 151 - Arm 6	Metformin	AMG 151 - Arm 6
Placebo Arm	Metformin	AMG 151 Placebo Arm

Primary Outcome Measures

Name	Time	Method
To evaluate the dose-effect relationship of AMG 151 compared to placebo on fasting plasma glucose in subjects with type 2 diabetes treated with metformin	Change in fasting plasma glucose levels from baseline to Day 28

Secondary Outcome Measures

Name	Time	Method
To assess the effect of AMG 151 on postprandial glucose levels in response to a meal tolerance test	Change in area under the curve from 0-4 hours (AUC0-4hr) glucose after a meal tolerancetest from baseline to Day 28, Change in incremental AUC0-4hr glucose after a meal tolerance test from baseline to Day 28
Adverse events	Incidence of serious adverse events from signing of ICF to Day 42. Incidence of non-serious adverse events from randomization to Day 42.

Trial Locations

Locations (1)

Research Site; 🇵🇷 San Juan, Puerto Rico