Trial record 4 of 309 for:
TODAY Type 2
A Safety PK/PD Study of SLV337 in Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Abbott Products
Collaborator:
Quintiles
Information provided by (Responsible Party):
Abbott ( Abbott Products )
ClinicalTrials.gov Identifier:
NCT00924534
First received: June 18, 2009
Last updated: December 30, 2011
Last verified: August 2011
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Purpose
The purpose of this study is to assess safety, tolerability, pharmacokinetics and pharmacodynamics of SLV337 in patients with type 2 diabetes
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes |
Drug: Placebo Drug: SLV337 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Double-blind, Randomized, Placebo-controlled, Parallel Group Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SLV337 in Patients With Type 2 Diabetes on Metformin Monotherapy |
Resource links provided by NLM:
Further study details as provided by Abbott:
Primary Outcome Measures:
- Change from Baseline in alanine amino transferase level to Day 35 [ Time Frame: 35 days ] [ Designated as safety issue: Yes ]
- Change from baseline in Creatinine level to Day 35 [ Time Frame: 35 days ] [ Designated as safety issue: No ]
- Change from baseline in the count of Red blood cells to Day 35 [ Time Frame: 35 days ] [ Designated as safety issue: No ]
- Change from baseline in White blood cells count to Day 35 [ Time Frame: 35 days ] [ Designated as safety issue: No ]
- Change from baseline in Creatinine kinase level to Day 35 [ Time Frame: 35 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in Fasting plasma glucose level to Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Change from baseline in Adiponectin level to Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Change from baseline in Triglycerides level to Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- Change from baseline in High density lipoprotein cholesterol level to Day 28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
| Enrollment: | 61 |
| Study Start Date: | December 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: 1 |
Drug: Placebo
Placebo
|
| Experimental: 2 |
Drug: SLV337
SLV337 400 mg/day
|
| Experimental: 3 |
Drug: SLV337
SLV337 800 mg/day
|
| Experimental: 4 |
Drug: SLV337
SLV337 1400 mg/day
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria Type 2 diabetes ,stable dose of Metformin,HbA1c >= 7%, but < 9% Exclusion Criteria Type 1 diabetes mellitus, Body Mass Index (BMI) >40.0 kg/m2, evidence of unstable cardiovascular diseases, NYHA class I to IV, ALT > 1.5 times UNL, creatinine clearance <60 mL/min
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924534
Locations
| Bulgaria | |
| Site Reference ID/Investigator# 54183 | |
| Dimitrovgrad, Bulgaria, 6400 | |
| Site Reference ID/Investigator# 54182 | |
| Pleven, Bulgaria, 5800 | |
| Site Reference ID/Investigator# 44722 | |
| Plovdiv, Bulgaria, 4000 | |
| Site Reference ID/Investigator# 44723 | |
| Sofia, Bulgaria, 1407 | |
| Poland | |
| Site Reference ID/Investigator# 44725 | |
| Lubin, Poland, 59-301 | |
| Site Reference ID/Investigator# 44724 | |
| Pulawy, Poland, 24-100 | |
| Site Reference ID/Investigator# 54185 | |
| Radzymin, Poland, 05-250 | |
| Site Reference ID/Investigator# 44727 | |
| Ruda Slaska, Poland | |
| Site Reference ID/Investigator# 54184 | |
| Wroclaw, Poland, 50-349 | |
| South Africa | |
| Site Reference ID/Investigator# 44730 | |
| Cape Town, South Africa, 7937 | |
| Site Reference ID/Investigator# 44728 | |
| Cape Town, South Africa, 7130 | |
| Site Reference ID/Investigator# 44729 | |
| Johannesburg, South Africa, 2198 | |
Sponsors and Collaborators
Abbott Products
Quintiles
Investigators
| Study Director: | Francis Roy, MS | Abbott Products |
More Information
No publications provided
| Responsible Party: | Abbott ( Abbott Products ) |
| ClinicalTrials.gov Identifier: | NCT00924534 History of Changes |
| Other Study ID Numbers: | S337.2.001, 2009-011589-27 |
| Study First Received: | June 18, 2009 |
| Last Updated: | December 30, 2011 |
| Health Authority: | South Africa: Medicines Control Council Bulgaria: Ministry of Health Bulgaria: Bulgarian Drug Agency Poland: The Central Register of Clinical Trials Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products |
Keywords provided by Abbott:
|
type 2 diabetes interventional placebo controlled |
PK PD safety |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013