A Study of the Efficacy and Safety of Albiglutide in Subjects With Type 2 Diabetes With Renal Impairment.
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01098539
First received: April 1, 2010
Last updated: November 21, 2012
Last verified: August 2012
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Purpose
This randomized, double-blind, active-controlled study evaluates the efficacy and safety of a weekly dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Biological: albiglutide Drug: sitagliptin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Active-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of Albiglutide as Compared With Sitagliptin in Subjects With Type 2 Diabetes Mellitus With Renal Impairment |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Evaluation of the efficacy of albiglutide as compared with sitagliptin on the HbA1c change from Baseline. [ Time Frame: Week 26 ] [ Designated as safety issue: No ]change from baseline
Secondary Outcome Measures:
- HbA1c change from Baseline over time [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]change from baseline over time
- Fasting plasma glucose (FPG) change from Baseline over time [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]change from baseline over time
- Proportion of subjects at a HbA1c treatment goal of <7.0% or <6.5% [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]HbA1c responders
- Time to hyperglycemia rescue [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]measure of time taken to require rescue medication
- Change from Baseline in body weight [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]change from baseline
- The effect of plasma concentrations of albiglutide on glycemic control (population PK/PD) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]population PK/PD
| Enrollment: | 507 |
| Study Start Date: | May 2010 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: albiglutide
albiglutide weekly subcutaneous injection + sitagliptin matching placebo
|
Biological: albiglutide
albiglutide weekly subcutaneous injection + sitagliptin matching placebo
|
|
Active Comparator: sitagliptin
albiglutide matching placebo + sitagliptin
|
Drug: sitagliptin
albiglutide matching placebo + sitagliptin (25mg, 50mg or 100mg depending on level of renal impairment)
|
Detailed Description:
This randomized, double-blind, active-controlled, 2 parallel-group, multicenter study evaluates the efficacy and safety of a weekly subcutaneously injected dose of albiglutide as compared with sitagliptin. Subjects who are renally impaired with a historical diagnosis of type 2 diabetes mellitus and whose glycemia is inadequately controlled on their current regimen of diet and exercise or their antidiabetic therapy of metformin, thiazolidinedione, sulfonylurea, or any combination of these oral antidiabetic medications will be recruited into the study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Renally impaired with a historical diagnosis of type 2 diabetes mellitus and is experiencing inadequate glycemic control on their current regime of diet and exercise or their antidiabetic therapy of metformin, TZD, SU, or any combination of these oral antidiabetic medications
- BMI >/=20 kg/m2 and </=45 kg/m2
- Fasting C-peptide >/=0.8 ng/mL (>/=0.26 nmol/L)
- HbA1c between 7.0% and 10.0%, inclusive.
Exclusion Criteria:
- History of cancer
- History of treated diabetic gastroparesis
- Current biliary disease or history of pancreatitis
- History of significant gastrointestinal surgery
- Recent clinically significant cardiovascular and/or cerebrovascular disease
- History of human immunodeficiency virus infection
- Abnormal liver function or acute symptomatic infection with hepatitis B or hepatitis C
- Female subject is pregnant (confirmed by laboratory testing), lactating, or <6 weeks postpartum
- Known allergy to any GLP 1 analogue, sitagliptin, other study medications' excipients, excipients of albiglutide, or Baker's yeast
- Receipt of any investigational drug or sitagliptin within the 30 days or 5 half lives, whichever is longer, before Screening or a history of receipt of an investigational antidiabetic drug within the 3 months before randomization or receipt of albiglutide in previous studies
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01098539
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| United States, Alabama | |
| GSK Investigational Site | |
| Gulf Shores, Alabama, United States, 36542 | |
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| Huntsville, Alabama, United States, 35801 | |
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| Toney, Alabama, United States, 35773 | |
| United States, Arizona | |
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| Phoenix, Arizona, United States, 85028 | |
| United States, California | |
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| Fresno, California, United States, 93720 | |
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| Huntington Beach, California, United States, 92648 | |
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| Los Angeles, California, United States, 90073 | |
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| Los Angeles, California, United States, 90017 | |
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| Los Angeles, California, United States, 90022 | |
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| Los Gatos, California, United States, 95032 | |
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| Orange, California, United States, 92868 | |
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| San Diego, California, United States, 92120 | |
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| San Diego, California, United States, 92161 | |
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| San Dimas, California, United States, 91773 | |
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| Tarzana, California, United States, 91356 | |
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| West Hills, California, United States, 91307 | |
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| Whittier, California, United States, 90603 | |
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| Doral, Florida, United States, 33172 | |
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| Hollywood, Florida, United States, 33021 | |
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| Jacksonville, Florida, United States, 32205 | |
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| Miami, Florida, United States, 33136 | |
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| Miami Beach, Florida, United States, 33141 | |
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| New Port Richey, Florida, United States, 34653 | |
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| Mission, Kansas, United States, 66202 | |
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| Lexington, Kentucky, United States, 40504 | |
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| Alexandria, Louisiana, United States, 71301 | |
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| Bangor, Maine, United States, 04401 | |
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| Hyattsville, Maryland, United States, 20782 | |
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| Omaha, Nebraska, United States, 68131 | |
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| Altoona, Pennsylvania, United States, 16602 | |
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| Downington, Pennsylvania, United States, 19335 | |
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| Philadelphia, Pennsylvania, United States, 19146 | |
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| Charleston, South Carolina, United States, 29412 | |
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| Columbia, South Carolina, United States, 29204 | |
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| Greer, South Carolina, United States, 29651 | |
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| North Myrtle Beach, South Carolina, United States, 29582 | |
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| Taylors, South Carolina, United States, 29687 | |
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| Bristol, Tennessee, United States, 37620 | |
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| Franklin, Tennessee, United States, 37067 | |
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| Knoxville, Tennessee, United States, 37923 | |
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| Tullahoma, Tennessee, United States, 37398 | |
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| Humble, Texas, United States, 77338 | |
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| Sugarland, Texas, United States, 77479 | |
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| Tomball, Texas, United States, 77375 | |
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| Bountiful, Utah, United States, 84010 | |
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| South Burlington, Vermont, United States, 05403 | |
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| Manassas, Virginia, United States, 20110 | |
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| Norfolk, Virginia, United States, 23510 | |
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| Salem, Virginia, United States, 24153 | |
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| Tacoma, Washington, United States, 98405 | |
| Australia, New South Wales | |
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| Camperdown, New South Wales, Australia, 2050 | |
| Australia, Queensland | |
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| Auchenflower, Queensland, Australia, 4066 | |
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| Herston, Queensland, Australia, 4029 | |
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| Kippa Ring, Queensland, Australia, 4021 | |
| Australia, Victoria | |
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| Box Hill, Victoria, Australia, 3128 | |
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| Clayton, Victoria, Australia, 3168 | |
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| Heidelberg, Victoria, Australia, 3081 | |
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| Melbourne, Victoria, Australia, 3135 | |
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| Parkville, Victoria, Australia, 3050 | |
| Australia, Western Australia | |
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| Fremantle, Western Australia, Australia, 6160 | |
| Australia | |
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| Garran, ACT, Australia, 2606 | |
| Brazil | |
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| Porto Alegre, Rio Grande Do Sul, Brazil, 90035-170 | |
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| Brasília, Brazil, 71625-009 | |
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| Mogi das Cruzes, Brazil, 08780 - 090 | |
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| São Paulo, Brazil, 05302-001 | |
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| Barrangquilla, Colombia | |
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| Bogota, Colombia, 110221 | |
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| Floridablanca-Santander, Colombia | |
| Germany | |
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| Bad Nauheim, Hessen, Germany, 61231 | |
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| Bad Lauterberg, Niedersachsen, Germany, 37431 | |
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| Mainz, Rheinland-Pfalz, Germany, 55116 | |
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| Dresden, Sachsen, Germany, 01307 | |
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| Berlin, Germany, 10115 | |
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| Ahmedabad, India, 380015 | |
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| Bangalore, India, 560 010 | |
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| Bangalore, India, 560 054 | |
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| Bangalore, India, 560052 | |
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| Bangalore, India, 560043 | |
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| Belgaum, India, 590001 | |
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| Belgaum,, India, 590010 | |
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| Chennai, India, 600013 | |
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| Lucknow, India, 226005 | |
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| Nasik, India, 422013 | |
| Israel | |
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| Ashkelon, Israel, 78278 | |
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| Beer-Sheva, Israel, 84101 | |
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| Haifa, Israel, 31096 | |
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| Holon, Israel, 58100 | |
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| Kfar Saba, Israel, 44281 | |
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| Nahariya, Israel | |
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| Safed, Israel, 13110 | |
| Korea, Republic of | |
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| Seongnam-si, Korea, Republic of, 463712 | |
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| Seoul, Korea, Republic of, 139-872 | |
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| Seoul, Korea, Republic of, 135-720 | |
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| Seoul, Korea, Republic of, 136-705 | |
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| Seoul, Korea, Republic of, 137-701 | |
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| Suwon, Kyonggi-do, Korea, Republic of, 443-721 | |
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| Cebu City, Philippines, 6000 | |
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| Makati City, Philippines, 1218 | |
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| Tagbilaran City, Philippines, 6300 | |
| Russian Federation | |
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| Nizhniy Novgorod, Russian Federation, 603126 | |
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| Saratov, Russian Federation, 410030 | |
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| St'Petersburg, Russian Federation, 194156 | |
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| Yaroslavl, Russian Federation, 150062 | |
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| Port Elizabeth, Eastern Cape, South Africa, 6014 | |
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| Johannesburg, Gauteng, South Africa, 2013 | |
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| Lenasia, Gauteng, South Africa, 1827 | |
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| Pretoria, Gauteng, South Africa, 0084 | |
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| Durban, KwaZulu- Natal, South Africa, 4092 | |
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| Phoenix, KwaZulu- Natal, South Africa, 4068 | |
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| Houghton, South Africa, 2198 | |
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| Somerset West, South Africa, 07129 | |
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| Tygerberg, South Africa, 7505 | |
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| Alicante, Spain, 03114 | |
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| La Coruña, Spain, 15006 | |
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| Málaga, Spain, 29010 | |
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| Palma de Mallorca, Spain, 07014 | |
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| Santiago de Compostela, Spain, 15706 | |
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| Sevilla, Spain, 41003 | |
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| Torrevieja (Alicante), Spain, 03186 | |
| Taiwan | |
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| Kaohsiung, Taiwan, 833 | |
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| Taichung, Taiwan, 404 | |
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| Tainan, Taiwan, 71044 | |
| United Kingdom | |
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| Coventry, West Midlands, United Kingdom, CV2 2DX | |
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| Birmingham, United Kingdom, B9 5SS | |
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| Hertfordshire, United Kingdom | |
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| Hull, United Kingdom, HU3 2RW | |
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| Livingston, United Kingdom, EH54 6PP | |
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| London, United Kingdom, SE1 9NH | |
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| Plymouth, United Kingdom, PL6 8BX | |
Sponsors and Collaborators
GlaxoSmithKline
Investigators
| Study Director: | GSK Clinical Trials | GlaxoSmithKline |
More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01098539 History of Changes |
| Other Study ID Numbers: | 114130 |
| Study First Received: | April 1, 2010 |
| Last Updated: | November 21, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by GlaxoSmithKline:
|
sitagliptin albiglutide renal impairment |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Renal Insufficiency Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Kidney Diseases Urologic Diseases |
Sitagliptin Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013