Investigate Effect of AMG 151 on 24-hour Ambulatory Blood Pressure & Glucose Levels in Type 2 Diabetes Mellitus Subjects
Study Details
Study Description
Brief Summary
This is a phase 1, randomized, double-blind, placebo-controlled, 2-way crossover study to evaluate the effect of AMG 151 on 24-hour ambulatory blood pressure and glucose levels in subjects with type 2 diabetes mellitus who are on a stable regimen of metformin alone, metformin and a dipeptidyl peptidase-4 inhibitor (DPP4), metformin and a thiazolidinedione (TZD), or metformin, a DPP4, and a TZD for a minimum of 3 months prior to randomization.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: AMG 151
|
Drug: AMG 151
Eligible subjects will be randomly assigned (1:1) to receive AMG 151 and matching placebo in 1 of 2 sequences over 2 treatment periods.
|
| Placebo Comparator: Placebo
|
Other: Placebo
Eligible subjects will be randomly assigned (1:1) to receive AMG 151 and matching placebo in 1 of 2 sequences over 2 treatment periods.
|
Outcome Measures
Primary Outcome Measures
- Mean 24-hour systolic blood pressure [After 14 days of AMG 151 or placebo treatment]
Secondary Outcome Measures
- Mean 24-hour diastolic blood pressure [After 14 days of AMG 151 or placebo treatment]
- Mean 24-hour heart rate [After 14 days of AMG 151 or placebo treatment]
- 24-hour concentration time profile of glucose level from continuous glucose monitoring [Day 1 and day 14 of each period]
- Fasting plasma glucose and fructosamine [After 13 days of AMG 151 or placebo treatment]
- Plasma glucose 2 hours after time 0 of mixed meal tolerance test [After 13 days of AMG 151 or placebo treatment]
- 4-hour concentration time profile of glucose after the mixed meal tolerance test [After 13 days of AMG 151 or placebo treatment]
- Safety end points will include the incidence of treatment emergent adverse events. [Up to 2 Months]
- Serum AMG 151 concentration [Up to 2 Months]
- Safety end points will include laboratory safety tests. [Up to 2 Months.]
- Safety end points will include vital signs. [Up to 2 Months]
- Safety end points will include ECGs. [Up to 2 Months]
Eligibility Criteria
Criteria
Inclusion Criteria
-
Subjects with type 2 diabetes mellitus
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On a stable regimen of metformin alone, metformin and a DPP4, metformin and a TZD, or metformin, a DPP4, and a TZD for a minimum of 3 months prior to randomization
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Body mass indices > 25 and < 45 kg/m2
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Hemoglobin A1c levels ≥ 7.0% and ≤ 11.0% at screening
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Fasting C-peptide levels ≥ 0.2 nmol/L at screening
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Subject with a history of hypertension must be on a stable antihypertensive treatment (s) (type of medication, dose, and regimen) for at least 6 weeks prior to the first dose of investigational product
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Other criteria may apply
Exclusion Criteria
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Subject has type 1 diabetes mellitus or history of type 1 diabetes mellitus
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Subject has had 2 or more emergency room visits or hospitalizations due to poor glucose control in the 6 months prior to screening
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Poorly controlled hypertension defined as diastolic pressure ≥ 95 mmHg or systolic ≥ 155 mmHg (confirmed by a repeat assessment) at screening
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Triglycerides ≥ 400 mg/dL (4.52 mmol/L) at screening
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Use of any known cytochrome P450 (CYP) inducers within 30 days or 5 half-lives (whichever is longer), prior to receiving the first dose of investigational product.
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Use of any known inhibitors of CYP3A4/P-glycoprotein within the 14 days or 5 half lives (whichever is longer) prior to receiving the first dose of investigational product
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Other criteria may apply
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Research Site | San Diego | California | United States | 92161 |
Sponsors and Collaborators
- Amgen
Investigators
- Study Director: MD, Amgen
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20120189