Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Eudract-2008-000976-26 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saxagliptin 5 mg + Metformin | Experimental |
| |
| Placebo + Metformin | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saxagliptin | Drug | Tablets, Oral, 5mg, once daily, 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4 | Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value. | Baseline, Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4 | Adjusted mean change from baseline in 4-hour mean weighted postprandial (after mealtime) plasma glucose after the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value. | Baseline, Week 4 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dedicated Phase I, Inc. | Phoenix | Arizona | 85013 | United States | ||
| Amcr Institute, Inc |
218 subjects were enrolled and 128 entered the 4-week dietary and exercise, and metformin extended release (XR) lead-in period. Thirty-five subjects did not enter treatment period (21 no longer met study criteria, 7 withdrew consent, 7 for poor protocol compliance).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Saxagliptin 5 mg + Metformin | Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR. |
| FG001 | Placebo + Metformin | Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Tablets, Oral, 0 mg, once daily, 4 weeks |
|
| Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4 | Adjusted mean change from baseline in 2-hour postprandial plasma glucose after the evening meal during 24-hour domicile visits, evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value. | Baseline, Week 4 |
| Change From Baseline in Mean Daily Glucose at Week 4 | Adjusted mean change from baseline in daily glucose at Week 4. Mean daily glucose was calculated based on finger stick glucose measurements collected by the subjects at home in a 3-day period, prior to collection of the 24-hour blood samples at baseline and Week 4. Mean change from baseline was adjusted for baseline value. | Baseline, Week 4 |
| Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4 | Adjusted mean change from baseline in 2-day average of FPG at baseline and Week 4. Baseline value=the average of the values at Day -2 and Day 1. Week 4 measurement=average of Day 26 and Day 28 value during the double blind period. At pre-randomization and Day 28 the FPG value was the plasma glucose value collected 30 minutes prior to the morning meal during domicile visits. Mean change from baseline was adjusted for baseline value. | Baseline, Week 4 |
| Escondido |
| California |
| 92026 |
| United States |
| Irvine Center For Clinical Research, Inc. | Irvine | California | 92618 | United States |
| Pacific Sleep Medicine Services (Avastra Clinical Trials) | Redlands | California | 92373 | United States |
| Advantage Clinical Research | Santa Ana | California | 92701 | United States |
| Orange County Research Center | Tustin | California | 92780 | United States |
| River Birch Research Alliance, Llc | Blue Ridge | Georgia | 30513 | United States |
| Endocrine Research Solutions, Inc. | Roswell | Georgia | 30076 | United States |
| Jasper Clinic, Inc. | Kalamazoo | Michigan | 49007 | United States |
| Clinilabs, Inc. | New York | New York | 10019 | United States |
| Covance Cru, Inc. | Portland | Oregon | 97239 | United States |
| Dgd Research, Inc. | San Antonio | Texas | 78229 | United States |
| Avastra Clinical Trials | Midvale | Utah | 84047 | United States |
| Local Institution | Martínez | Buenos Aires | B1640AOD | Argentina |
| Local Institution | Holon | 58100 | Israel |
| Local Institution | Jerusalem | 91120 | Israel |
| Local Institution | Kfar Saba | 44281 | Israel |
| Local Institution | Ẕerifin | 70300 | Israel |
| Local Institution | Milan | 20132 | Italy |
| Local Institution | Aguascalientes | Aguascalientes | 20230 | Mexico |
| Local Institution | Monterrey | Nuevo León | 64460 | Mexico |
| Local Institution | Cebu City | 6000 | Philippines |
| Local Institution | Marikina City | 1800 | Philippines |
| Local Institution | Ponce | Puerto Rico | 00717 | Puerto Rico |
| Local Institution | Lund | Sweden | 221 85 | Sweden |
| Local Institution | Gothenburg | 413 45 | Sweden |
| Local Institution | Huddinge | 141 86 | Sweden |
| Randomized Subjects Data Set |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Saxagliptin 5 mg + Metformin | Saxagliptin tablets, 5 mg, taken orally once daily for 4 weeks, plus metformin XR. |
| BG001 | Placebo + Metformin | Placebo tablets, taken orally once daily for 4 weeks, plus metformin XR. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4 | Adjusted mean change from baseline in MWG achieved with saxagliptin 5 mg plus metformin XR versus placebo plus metformin XR at Week 24. MWG was calculated as the area under the curve (AUC) for the full 24 hours expressed as average mg/dL. Glucose measurements were collected 30 minutes before and just prior to each meal (0 minutes) and 30, 60, 120, and 180 minutes after each meal (with 1 additional measurement at 240 minutes after the evening meal), midnight, 3 AM, and at end-of-domicile visit 24 hours after the first measurement. Mean change from baseline was adjusted for baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 4 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4 | Adjusted mean change from baseline in 4-hour mean weighted postprandial (after mealtime) plasma glucose after the evening meal during 24-hour domicile visits evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4 | Adjusted mean change from baseline in 2-hour postprandial plasma glucose after the evening meal during 24-hour domicile visits, evaluated both at pre-randomization (baseline) and at Week 4. Mean change from baseline was adjusted for baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Mean Daily Glucose at Week 4 | Adjusted mean change from baseline in daily glucose at Week 4. Mean daily glucose was calculated based on finger stick glucose measurements collected by the subjects at home in a 3-day period, prior to collection of the 24-hour blood samples at baseline and Week 4. Mean change from baseline was adjusted for baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 4 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4 | Adjusted mean change from baseline in 2-day average of FPG at baseline and Week 4. Baseline value=the average of the values at Day -2 and Day 1. Week 4 measurement=average of Day 26 and Day 28 value during the double blind period. At pre-randomization and Day 28 the FPG value was the plasma glucose value collected 30 minutes prior to the morning meal during domicile visits. Mean change from baseline was adjusted for baseline value. | Randomized participants who took at least 1 dose of double-blind treatment. To be included in an analysis of change from baseline to Week 4 the subject must have had a baseline and a Week 4 measurement. | Posted | Mean | Standard Error | mg/dL | Baseline, Week 4 |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PLACEBO + MET | 0 | 47 | 5 | 47 | |||
| EG001 | SAXA 5MG + MET | 0 | 46 | 1 | 46 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| HEADACHE | Nervous system disorders | MedDRA 11.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 11.1 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boaz Hirschberg | AstraZeneca Pharmaceuticals | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C502994 | saxagliptin |
Not provided
Not provided
Not provided
| >= 65 years to <75 years |
|
| >= 75 years |
|
| Male |
|
| Black/African American |
|
| Asian |
|
| Other |
|
| Adjusted Mean Change from Baseline |
|
Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin.
| No |
| Superiority or Other |
|
|
|
|
|
|
|
|