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Effect of Repaglinide and Metformin Combination Tablet or Rosiglitazone and Metformin in Fixed Dose Combination on Blood Glucose Control in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00399711
Recruitment Status : Completed
First Posted : November 15, 2006
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This trial is conducted in the United States of America (USA). This trial compares the changes in HbA1c after 26 weeks of repaglinide and metformin fixed dose combination tablet given as twice daily versus three times daily regimens or versus twice daily rosiglitazone and metformin fixed dose combination tablet in subjects with type 2 diabetes currently on monotherapy.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 2 Drug: repaglinide and metformin combination tablet Drug: rosiglitazone and metformin combination tablet Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 560 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Repaglinide and Metformin Combination Tablet (NN4440) in a TID Regimen Compared to a BID Regimen and BID Avandamet in Subjects With Type 2 Diabetes: A Twenty-Six Week, Open-Label, Multicenter, Randomized, Parallel Group Trial to Investigate Efficacy and Safety
Study Start Date : November 2006
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. HbA1c [ Time Frame: After 26 weeks of treatment ]

Secondary Outcome Measures :
  1. Change in 8-point Glucose Profiles
  2. Change in Lipid Profile
  3. Events of hypoglycemia
  4. Safety parameters
  5. Change in Fasting Plasma Glucose
  6. Waist/hip ratio change
  7. Change in body weight
  8. Percentage of subjects achieving sudden levels of HbA1c

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes for at least 3 months
  • HbA1c between 7.5-11.0% on monotherapy or
  • HbA1c between 7.0-10.0% on dual therapy
  • BMI maximum 45 kg/m2

Exclusion Criteria:

  • Any clinically significant disease history in the opinion of the investigator
  • Severe heart disease
  • Pregnancy
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00399711


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452), MD Novo Nordisk A/S
More Information
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Additional Information:

Publications of Results:

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00399711    
Other Study ID Numbers: NN4440-1794
First Posted: November 15, 2006    Key Record Dates
Last Update Posted: February 10, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Rosiglitazone
Repaglinide
Hypoglycemic Agents
Physiological Effects of Drugs