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A Study of Saxagliptin in Subjects With Type 2 Diabetes Who Have Inadequate Blood Sugar Control With Sulfonylureas

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ClinicalTrials.gov Identifier: NCT00313313
Recruitment Status : Completed
First Posted : April 12, 2006
Results First Posted : September 25, 2009
Last Update Posted : May 4, 2015
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Brief Summary:
The purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes

Condition or disease Intervention/treatment Phase
Diabetes Drug: Saxagliptin Drug: Glyburide Drug: Placebo Drug: Metformin Phase 3

Detailed Description:
All subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. Subjects who complete the short-term period will be eligible to enter the long term extension period. Also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.Rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 768 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination With Glyburide in Subjects With Type 2 Diabetes Who Have Inadequate Glycemic Control With Glyburide Alone
Study Start Date : April 2006
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Saxagliptin 2.5 mg + Glyburide 7.5 mg (A)
Metformin 500-2500 mg (as needed)
Drug: Saxagliptin
Tablets, Oral, 2.5 mg, Daily AM, (24 weeks short-term [ST], 12 months long-term [LT])
Other Name: BMS-477118

Drug: Glyburide
Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)

Drug: Metformin
Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)

Experimental: Saxagliptin 5 mg + Glyburide 7.5 mg (B)
Metformin 500-2500 mg (as needed)
Drug: Saxagliptin
Tablets, Oral, 5 mg, Daily AM (24 weeks ST, 12 months LT).
Other Name: BMS-477118

Drug: Glyburide
Capsules, Oral, OL, 7.5 mg, Daily, AM (24 weeks ST, 12 months LT)

Drug: Metformin
Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)

Placebo Comparator: Placebo + Glyburide 7.5 mg (C)
Metformin 500-2500 mg (as needed)
Drug: Placebo
Tablets, Oral, 0 mg, Daily AM/PM, (24 weeks ST, 12 months LT)

Drug: Glyburide
Capsules, Oral, DB Glyburide, 2.5 mg titrated to 7.5 mg + 7.5 mg OL, Daily AM/PM (24 weeks ST, 12 months LT)

Drug: Metformin
Tablets, Oral, OL, 500 - 2500 mg, 1 or 2 times per day (12 months LT)




Primary Outcome Measures :
  1. Change From Baseline in Hemoglobin A1c (A1C) at Week 24 [ Time Frame: Baseline, Week 24 ]
    Mean change from baseline in A1C at Week 24, adjusted for baseline value.


Secondary Outcome Measures :
  1. Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline, Week 24 ]
    Mean change from baseline in FPG at Week 24, adjusted for baseline value.

  2. Percentage of Participants Achieving A1C < 7% at Week 24 [ Time Frame: Week 24 ]
    Percentage of participants achieving A1C < 7%, the American Diabetes Association's defined goal for glycemia, at each dose of saxagliptin plus glyburide versus placebo plus upward titrated glyburide at Week 24.

  3. Changes From Baseline in Postprandial Glucose (PPG) Area Under the Curve (AUC) Response to an Oral Glucose Tolerance Test (OGTT) at Week 24 [ Time Frame: Baseline, Week 24 ]
    Mean change from baseline for 0 to 180 minutes PPG AUC at Week 24, adjusted for baseline values.



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Ages Eligible for Study:   18 Years to 77 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 Diabetes.
  • Treated with a sulfonylurea for at least 2 months.
  • Inadequate blood sugar control.
  • Are not on any other medications to lower blood sugar.
  • No major heart, liver or kidney problems.
  • Women not pregnant or breast feeding.

Information from the National Library of Medicine

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): NCT00313313


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Sponsors and Collaborators
AstraZeneca

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00313313     History of Changes
Other Study ID Numbers: CV181-040
First Posted: April 12, 2006    Key Record Dates
Results First Posted: September 25, 2009
Last Update Posted: May 4, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Saxagliptin
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action