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Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

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Official Title

The purpose of this study is to compare the reduction in hemoglobin A1C (A1C) for participants taking saxagliptin in combination with metformin immediate release (IR) versus metformin IR alone.

Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus

Tablets, Oral, 2.5 mg, Twice daily, 12 weeks

Tablets, Oral, Placebo, Twice daily, 12 weeks

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Clinical Therapeutics Corporation

Wells Institute For Health Awareness

Tidewater Integrated Medical Research

Southland Clinical Research Center, Inc.

Middle Georgia Drug Study Center, Llc

Newark Physician Associates

Village Family Practice

Holston Medical Group

Integrated Medical Group Pc/Fleetwood Clinical Research

Local Institution

Integris Family Care Yukon

Southeastern Research Associates, Inc

Southwest Clinical Research Centers, Llc

Community Health Care Of Manchester

John Muir Physician Network Clinical Research Center

Midwest Regional Research, Inc.

Williamette Valley Clinical Studies

Nextphase Clinical Trials, Inc.

Integris Family Care South

Jolene K. Berg, Md., Dgd Research, Inc.

Family Care Associates Of Nw Florida

Jackson Clinic

Ritchken & First M.D.'S

Central Florida Clinical Trials, Inc.

Louisiana Heart Center Research

Torrance Clinical Research

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, Twice Daily, in Combination with Metformin IR in Subjects with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin IR Alone

Age Continuous

Gender, Male/Female

Race (NIH/OMB)

Region of Enrollment

Mean Height

Study Specific Characteristic

Mean Weight

Mean Body Mass Index (BMI)

Participant Body Mass Index

Mean time since the time of diagnosis of Type 2 Diabetes Mellitus.

Mean Duration of Type 2 Diabetes Mellitus

Mean Metformin Dose at Baseline

Mean Baseline

Adjusted Mean Change from Baseline

Randomized participants with a measurement at the specified timepoint with Last Observation Carried Forward (LOCF).

Mean Baseline and Change from Baseline in Fasting Plasma Glucose (FPG)

Adjusted for baseline. Calculated using the method by Zhang et al. (Zhang M, Tsiatis A, Davidian M. Improving efficiency of inference in randomized clinical trials using auxiliary covariates. Biometrics. Published online on January 11, 2008; Digital Object Identifier: 10.1111/j.1541-0420.2007.00976.x.)

Randomized participants with measurement at timepoint with LOCF.

Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C < 7.0%) at Week 12

Percentage of Participants Achieving a Therapeutic Glycemic Response (A1C <= 6.5%) at Week 12

At Least 1 AE

At Least 1 Related AE

Deaths

At Least 1 SAE

At Least 1 Related SAE

Discontinued Due to SAEs

Discontinued Due to AEs

AE = any new untoward medical occurrence/worsening of a pre-existing medical condition which does not necessarily have a causal relationship with this treatment.SAE = any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, results in development of drug dependency or drug abuse, is an important medical event. Treatment-related=Possible, Probable, or Certain relationship to drug.

Participant Adverse Event (AE), Related AE, Serious Adverse Event (SAE), Related SAE, and Discontinued Due to AEs Summary

Hypoglycemic Events are based upon the Saxagliptin Predefined List of Events, which included hypoglycemia, blood glucose decreased, and hypoglycemic unconsciousness.

Participants with Reported Hypoglycemia AEs During Double-Blind Treatment Period

Confirmed hypoglycemia was defined by a fingerstick glucose value <= 50 mg/dL
with associated hypoglycemia symptoms.

Participants With Confirmed Hypoglycemia

Baseline Normal

Baseline Abnormal

Week 12 Normal

Week 12 Abnormal

Shifted Normal to Abnormal

Shifted Abnormal to Normal

Abnormal ECGs were defined as those not within the normal limits for the participant, according to the investigator. 'Shifted Normal to Abnormal' and 'Shifted Abnormal to Normal' references a change from measurements at Baseline to those at Week 12.

All treated participants, excluding those with missing values.

Participant Electrocardiogram (ECG) Status at Baseline and Week 12

Baseline SBP for Week 4 cohort (n=74, 84)

Baseline DBP for Week 4 cohort (n=74, 84)

SBP Change From Baseline at Week 4 (n=74, 84)

DBP Change From Baseline at Week 4 (n=74, 84)

Baseline SBP for Week 8 cohort (n=70, 81)

Baseline DBP for Week 8 cohort (n=70, 81)

SBP Change From Baseline at Week 8 (n=70, 81)

DBP Change From Baseline at Week 8 (n=70, 81)

Baseline SBP for Week 12 cohort (n=66, 77)

Baseline DBP for Week 12 cohort (n=66, 77)

SBP Change From Baseline at Week 12 (n=66, 77)

DBP Change From Baseline at Week 12 (n=66, 77)

Baseline values reference the measurement for the cohort of participants evaluated at the given time point.

All treated participants. n= number of participants with measurement at time point.

Baseline and Mean Change From Baseline in Participant Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Baseline HR for Week 4 cohort (n=74, 84)

HR Change From Baseline at Week 4 (n=74, 84)

Baseline HR for Week 8 cohort (n=70, 81)

HR Change From Baseline at Week 8 (n=70, 81)

Baseline HR for Week 12 cohort (n=66, 77)

HR Change From Baseline at Week 12 (n=66, 77)

Baseline and Mean Change From Baseline in Participant Heart Rate (HR)

Baseline

Adjusted Mean Change From Baseline

Randomized participants with both a baseline value and post-baseline value (up to Week 12).

Mean Hemoglobin A1C (A1c) and Change from Baseline to Week 12

Hemoglobin < 8 g/dL

Hematocrit < 0.75 prior to dosing

Platelets < 50 x 10^9 c/L

Platelets > 1.5 x ULN

Leukocytes < 2 x 10^3 c/uL

Neutrophils < 1 x 10^3 c/uL

Eosinophils > 0.9 x 10^3 c/uL

Lymphocytes <= 0.75 x 10^3 c/uL

Alkaline Phosphatase >3x prior to dosing and > ULN

Aspartate Aminotransferase > 3x ULN

Aspartate Aminotransferase > 5x ULN

Alanine Aminotransferase > 3x ULN

Alanine Aminotransferase > 5x ULN

Total Bilirubin > 2 mg/dL

Total Bilirubin > 1.5x ULN

Blood Urea Nitrogen > 2x prior to dosing and > ULN

Creatinine > 2.5 mg/dL

Serum Sodium <0.9x pre-Rx and <= 130 mEq/

Serum Sodium >1.1x pre-Rx and >= 150 mEq/L

Serum Potassium <=0.8x pre-Rx and <= 3.2 mEq/L

Serum Potassium >=1.2x pre-Rx and >= 6.0 mEq/L

Serum Chloride <90 mEq/L

Serum Chloride > 120 mEq/L

Albumin <0.9x LLN, or if pre-Rx<LLN use <0.75x

Creatinine Kinase > 5x ULN

Fasting Plasma Glucose   < 50 mg/dL

Fasting Plasma Glucose   > 500 mg/dL

Plasma Glucose Unspecified < 50 mg/dL

Plasma Glucose Unspecified > 500 mg/dL

A laboratory value was considered a marked abnormality if it is outside the pre-defined criteria for marked abnormality and the on-treatment value was more extreme (farther from the limit) than the baseline value. ULN=upper limit of normal; LLN=lower limit of normal.

Participants Experiencing Changes From Baseline in Laboratory Parameters that Met the Marked Abnormality Criteria

Urine Protein (n=74, 84)

Urine Blood (n=74, 84)

Urine Red Blood Cells  (n=7, 10)

Urine White Blood Cells  (n=16, 18)

Marked abnormality criteria were urine protein: if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4; urine blood: if pre-Rx=0, use >=2, if pre-Rx=0.5 or 1, use >=3, if pre-Rx=2, use >=4; Urine red blood cell count (RBC): if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4; urine white blood cell count (WBC): if pre-Rx=o use >=2, if pre-Rx =0.5 or 1 use >=3, if pre-Rx =2, use >=4.

All treated participants. N = number of participants analyzed and n = the number of participants with values available for each specific measurement.

Participants Experiencing Changes From Baseline in Urinalysis Parameters that Met the Marked Abnormality Criteria

Overall Study

Of the 166 subjects who entered the lead-in period, 6 discontinued: 3 withdrawal of consent, 1 poor/noncompliance, 1 adverse event (AE; abdominal pain secondary to partial small bowel obstruction), and 1 elevated liver enzymes that did not meet study exclusion criteria but was discontinued by the investigator.

Boaz Hirschberg

Arms	Assigned Interventions
Active Comparator: Saxagliptin plus metformin IR	Drug: Saxagliptin plus metformin IR Tablets, Oral, 2.5 mg, Twice daily, 12 weeks Other Name: BMS-477118 Other Name: Onglyza
Placebo Comparator: Placebo plus metformin IR	Drug: Placebo plus metformin IR Tablets, Oral, Placebo, Twice daily, 12 weeks

Efficacy and Safety Study of Saxagliptin + Metformin Immediate Release (IR) Versus Metformin IR Alone in Type 2 Diabetes Mellitus

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

BMS Clinical Trials Disclosure

Investigator Inquiry form

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Clinical Study Results.org

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator