Comparison of Repaglinide and Gliclazide in Chinese Subjects With Type 2 Diabetes Never Received Oral Antidiabetic Drug Treatment
NCT ID: NCT01022762
Last Updated: 2014-07-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
440 participants
INTERVENTIONAL
2009-11-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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repaglinide
1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
repaglinide
Individually adjusted dose for 16 weeks
gliclazide
80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
gliclazide
Individually adjusted dose for 16 weeks
Interventions
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repaglinide
Individually adjusted dose for 16 weeks
gliclazide
Individually adjusted dose for 16 weeks
Eligibility Criteria
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Inclusion Criteria
* Oral anti-diabetic drug (OAD) naïve (unsystematic OAD treatment 6 months prior to this trial is allowed)
* Insulin naïve (less than 1 week of daily use of insulin therapy before trial start is allowed)
* Lipid-lowing agent naïve
* HbA1c: 6.5-8.5%
* Fasting glucose: 6.1-13.0 mmol/L (110-234 mg/dl)
* Body Mass Index (BMI): 20-35 kg/m\^2
* Be able and willing to perform self-monitored plasma glucose (SMPG)
* Be able and willing to eat 3 main meals per day
* Only applicable to subjects who will participate in the subgroup study: Be able and willing to perform and complete IVGTT (intravenous glucose tolerance test) at additional visits
Exclusion Criteria
* Previous participation in this study
* Participation in a study of another investigational drug within 1 month prior to study start
18 Years
75 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Shanghai, Shanghai Municipality, China
Countries
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Related Links
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Clinical Trials at Novo Nordisk
Other Identifiers
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U1111-1111-9453
Identifier Type: OTHER
Identifier Source: secondary_id
AGEE-3783
Identifier Type: -
Identifier Source: org_study_id
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