Status:
COMPLETED
Exploratory Study to Access the Metabolic Effects of Ranolazine in Subjects With Type 2 Diabetes Mellitus When Added to Ongoing Non-insulin Antidiabetic Therapy
Lead Sponsor:
Gilead Sciences
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study enrolled participants with inadequately controlled type 2 diabetes mellitus (T2DM) despite non-insulin antidiabetic therapy in addition to diet and exercise, and would have benefited from a...
Eligibility Criteria
Inclusion
- Participant with T2DM on stable non-insulin antidiabetic therapy in addition to diet and exercise
- Body mass index (BMI) ≥ 25 kg/m\^2 and ≤ 40 kg/m\^2
- HbA1c 7 - 11%
- Ability and willingness to maintain a complete and accurate Subject Activity Log during the course of the trial
- Female of child-bearing potential must have agreed to use effective methods of contraception
- Ability to understand and willing to sign written informed consent
Exclusion
- Type 1 Diabetes Mellitus (T1DM)
- T2DM with history of or current insulin therapy. Prior use during pregnancy or gestational diabetes was acceptable.
- History of ketoacidosis or ketosis-prone diabetes
- Clinically significant complications of diabetes that in the judgment of the investigator would have made participant unsuitable to participate in this trial
- History of a severe episode of hypoglycemia
- Change in non-insulin antidiabetic therapy in addition to diet and exercise \< 2 months prior to screening
- Any clinically significant cardiovascular event \< 2 months prior to screening
- Clinically significant, inadequately controlled or unstable hypertension
- Hospitalization \< 2 months prior to screening
- Major surgery \< 3 months prior to screening
- Weight loss medication (prescription or non-prescription) \< 2 months prior to screening
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT01163721
Start Date
June 1 2010
End Date
November 1 2010
Last Update
September 23 2013
Active Locations (9)
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1
AMCR Institute
Escondido, California, United States, 92026
2
National Research Institute (NRI)
Los Angeles, California, United States, 90057
3
SeaView Research Inc.
Miami, Florida, United States, 33126
4
Orlando Clinical Research Center (OCRC)
Orlando, Florida, United States, 32809