AMG 151 Amgen Protocol Number 20100761

Sponsor

Amgen (Industry)

Overall Status

Completed

CT.gov ID

NCT01464437

Collaborator

(none)

236

Enrollment

Locations

Arms

Duration (Months)

3.1

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: AMG 151 Drug: Placebo Drug: Metformin Drug: AMG 151 Drug: AMG 151 Drug: AMG 151 Drug: AMG 151 Drug: AMG 151	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

236 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled Study to Explore Dose Effect and Frequency of Administration of AMG 151 in Subjects With Type 2 Diabetes Mellitus

Study Start Date :

Sep 1, 2011

Actual Primary Completion Date :

Oct 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: AMG 151 - Arm 1 AMG 151 - Arm 1	Drug: AMG 151 Drug: AMG 151 50 mg BID Drug: Metformin Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization.
Active Comparator: AMG 151 - Arm 2 AMG 151 - Arm 2	Drug: Metformin Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization. Drug: AMG 151 Drug: AMG 151 100 mg BID
Active Comparator: AMG 151 - Arm 3 AMG 151 - Arm 3	Drug: Metformin Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization. Drug: AMG 151 Drug: AMG 151 200 mg BID
Active Comparator: AMG 151 - Arm 4 AMG 151 - Arm 4	Drug: Metformin Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization. Drug: AMG 151 Drug: AMG 151 100 mg QD
Active Comparator: AMG 151 - Arm 5 AMG 151 - Arm 5	Drug: Metformin Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization. Drug: AMG 151 Drug: AMG 151 200 mg QD
Active Comparator: AMG 151 - Arm 6 AMG 151 - Arm 6	Drug: Metformin Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization. Drug: AMG 151 Drug: AMG 151 400 mg QD
Placebo Comparator: Placebo Arm AMG 151 Placebo Arm	Drug: Placebo Placebo Drug: Metformin Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization.

Outcome Measures

Primary Outcome Measures

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

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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Birmingham	Alabama	United States	35216
2	Research Site	Phoenix	Arizona	United States	85021
3	Research Site	Tucson	Arizona	United States	85704
4	Research Site	Little Rock	Arkansas	United States	72205
5	Research Site	Anaheim	California	United States	92801
6	Research Site	Chula Vista	California	United States	91911
7	Research Site	Fresno	California	United States	93720
8	Research Site	Greenbrae	California	United States	94904
9	Research Site	Inglewood	California	United States	90301
10	Research Site	Lomita	California	United States	90717
11	Research Site	Los Angeles	California	United States	90017
12	Research Site	Los Angeles	California	United States	90057
13	Research Site	Palm Desert	California	United States	92260
14	Research Site	Roseville	California	United States	95661
15	Research Site	San Diego	California	United States	92161
16	Research Site	San Jose	California	United States	95123
17	Research Site	Walnut Creek	California	United States	94598
18	Research Site	Watsonville	California	United States	95076
19	Research Site	Bradenton	Florida	United States	34208
20	Research Site	Brooksville	Florida	United States	34601
21	Research Site	Clearwater	Florida	United States	33756
22	Research Site	Fort Myers	Florida	United States	33912
23	Research Site	Kissimmee	Florida	United States	34741
24	Research Site	Maitland	Florida	United States	32751
25	Research Site	Palm Harbor	Florida	United States	34684
26	Research Site	Saint Petersburg	Florida	United States	33716
27	Research Site	St. Petersburg	Florida	United States	33709
28	Research Site	Tampa	Florida	United States	33606
29	Research Site	Winter Park	Florida	United States	32789
30	Research Site	Atlanta	Georgia	United States	30338
31	Research Site	Columbus	Georgia	United States	31904
32	Research Site	Dunwoody	Georgia	United States	30338
33	Research Site	Roswell	Georgia	United States	30076
34	Research Site	Meridian	Idaho	United States	83642
35	Research Site	Chigago	Illinois	United States	60607
36	Research Site	Indianapolis	Indiana	United States	46202
37	Research Site	Metairie	Louisiana	United States	70006
38	Research Site	Bethesda	Maryland	United States	20817
39	Research Site	St. Louis	Missouri	United States	63128
40	Research Site	Bozeman	Montana	United States	59718
41	Research Site	Las Vegas	Nevada	United States	89106
42	Research Site	Las Vegas	Nevada	United States	89117
43	Research Site	Mineola	New York	United States	11501
44	Research Site	Raleigh	North Carolina	United States	27612
45	Research Site	Shelby	North Carolina	United States	28150
46	Research Site	Bismarck	North Dakota	United States	58503
47	Research Site	Fargo	North Dakota	United States	58103
48	Research Site	Cincinnati	Ohio	United States	45227
49	Research Site	Cleveland	Ohio	United States	44122
50	Research Site	Dayton	Ohio	United States	45439
51	Research Site	Kettering	Ohio	United States	45429
52	Research Site	Norman	Oklahoma	United States	73069
53	Research Site	Oklahoma City	Oklahoma	United States	73112
54	Research Site	Rapid City	South Dakota	United States	57702
55	Research Site	Dallas	Texas	United States	75235
56	Research Site	Dallas	Texas	United States	75247
57	Research Site	Houston	Texas	United States	77029
58	Research Site	Houston	Texas	United States	77074
59	Research Site	San Antonio	Texas	United States	78229
60	Research Site	Draper	Utah	United States	84020
61	Research Site	Salt Lake City	Utah	United States	84124
62	Research Site	Midlothian	Virginia	United States	23114
63	Research Site	Norfolk	Virginia	United States	23510
64	Research Site	Richmond	Virginia	United States	23219
65	Research Site	Salem	Virginia	United States	24153
66	Research Site	Brno		Czech Republic	602 00
67	Research Site	Pardubice		Czech Republic	530 02
68	Research Site	Praha 3		Czech Republic	130 00
69	Research Site	Tallinn		Estonia	10128
70	Research Site	Lodz		Poland	90-368
71	Research Site	Warszawa		Poland	04-730
72	Research Site	Carolina		Puerto Rico	00983
73	Research Site	Cidra		Puerto Rico	00739
74	Research Site	San Juan		Puerto Rico	00909
75	Research Site	San Juan		Puerto Rico	00917
76	Research Site	San Juan		Puerto Rico	00920
77	Research Site	San Juan		Puerto Rico	00926-2832