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CompletedNCT00683657Updated Jun 1, 2015Results posted

Safety and Efficacy Study of Subjects That Are Taking Saxagliptin Added Onto Metformin XR Compared to Subjects Taking Metformin XR Alone

A Phase 3 interventional study of Saxagliptin and Placebo in Type 2 Diabetes, sponsored by AstraZeneca. Completed at 27 sites in 8 countries. Open to participants aged 18 Years to 77 Years. Per ClinicalTrials.gov, last updated 2015-06-01.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
93
Allocation
Randomized
Ages
18 Years to 77 Years
Sex
All
01

Study summary

This protocol will compare 24 hour glucose control for subject taking saxagliptin and metformin extended release (XR) versus metformin XR alone

02

Conditions studied

  • Type 2 Diabetes
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 93 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 77 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ≥18- and ≤77-years-old
  • Type 2 diabetes
  • Taking metformin immediate release (IR) or XR ≥1500 mg for at least 8 weeks as monotherapy
  • Glycosylated hemoglobin (A1C) ≥7% and ≤10%
  • Body mass index (BMI) ≤40 kg/m2

Exclusion criteria

Exclusion Criteria:

  • Women of childbearing potential unable or unwilling to use acceptable birth control
  • Women who are pregnant or breastfeeding
  • Significant cardiovascular history
  • Active liver disease
  • Renal impairment
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
93 participants (actual)

Study arms

  • Experimental
    Saxagliptin 5 mg + Metformin

    Drug: Saxagliptin

  • Placebo comparator
    Placebo + Metformin

    Drug: Placebo

Interventions

  • DrugSaxagliptin

    Tablets, Oral, 5mg, once daily, 4 weeks

    Also known as: BMS-477118

  • DrugPlacebo

    Tablets, Oral, 0 mg, once daily, 4 weeks

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, Week 4

Secondary outcomes

  1. 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.

    Time frame: Baseline, Week 4

  2. 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.

    Time frame: Baseline, Week 4

  3. 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.

    Time frame: Baseline, Week 4

  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.

    Time frame: Baseline, Week 4

07

Results

Posted Mar 10, 2010

Participant flow

Participant flow — Overall Study
MilestoneSaxagliptin 5 mg + MetforminPlacebo + Metformin
Started4647
Randomized subjects data set4647
Completed4546
Not completed11
Withdrew: Adverse event01
Withdrew: Subject withdrew consent10

Outcome measures

PrimaryChange 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.

Time frame:
Baseline, Week 4
Reported as:
Mean · mg/dL
Change From Baseline in 24-Hour Mean Weighted Glucose (MWG) at Week 4
mg/dLSaxagliptin 5 mg + MetforminPlacebo + Metformin
Baseline Mean177.5 ± 4.99181.2 ± 6.30
Week 4 Mean163.8 ± 5.09184.2 ± 7.05
Adjusted Mean Change from Baseline-13.8 ± 2.993.0 ± 2.89
Statistical analysis
  • Saxagliptin 5 mg + Metformin vs Placebo + Metformin · ANCOVA · p = 0.0001 (Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.) · Mean difference (final values): -16.8 · 95% CI -25.1 to -8.5Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin.
SecondaryChange 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.

Time frame:
Baseline, Week 4
Reported as:
Mean · mg/dL
Change From Baseline in 4-Hour Mean Weighted Postprandial Plasma Glucose at Week 4
mg/dLSaxagliptin 5 mg + MetforminPlacebo + Metformin
Baseline Mean212.1 ± 6.80211.1 ± 6.60
Week 4 Mean181.4 ± 6.79210.8 ± 8.02
Adjusted Mean Change from Baseline-30.7 ± 5.14-0.4 ± 4.90
Statistical analysis
  • Saxagliptin 5 mg + Metformin vs Placebo + Metformin · ANCOVA · p = <0.0001 (Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.) · Mean difference (final values): -30.2 · 95% CI -44.4 to -16.1Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin
SecondaryChange 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.

Time frame:
Baseline, Week 4
Reported as:
Mean · mg/dL
Change From Baseline in 2-Hour Postprandial Plasma Glucose After the Evening Meal at Week 4
mg/dLSaxagliptin 5 mg + MetforminPlacebo + Metformin
Baseline Mean237.6 ± 8.87233.1 ± 7.74
Week 4 Mean198.5 ± 8.82231.1 ± 9.22
Adjusted Change from Baseline-38.2 ± 7.49-2.8 ± 7.23
Statistical analysis
  • Saxagliptin 5 mg + Metformin vs Placebo + Metformin · ANCOVA · p = 0.0010 (Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.) · Mean difference (final values): -35.4 · 95% CI -56.2 to -14.7Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin
SecondaryChange 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.

Time frame:
Baseline, Week 4
Reported as:
Mean · mg/dL
Change From Baseline in Mean Daily Glucose at Week 4
mg/dLSaxagliptin 5 mg + MetforminPlacebo + Metformin
Baseline Mean179.0 ± 5.76184.9 ± 7.14
Week 4 Mean167.5 ± 4.87191.8 ± 8.41
Adjusted Change from Baseline-11.7 ± 3.027.0 ± 2.94
Statistical analysis
  • Saxagliptin 5 mg + Metformin vs Placebo + Metformin · ANCOVA · p = <0.0001 (Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.) · Mean difference (final values): -18.7 · 95% CI -27.1 to -10.3Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin
SecondaryChange 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.

Time frame:
Baseline, Week 4
Reported as:
Mean · mg/dL
Change From Baseline in 2-Day Average Fasting Plasma Glucose (FPG) at Week 4
mg/dLSaxagliptin 5 mg + MetforminPlacebo + Metformin
Baseline Mean152.2 ± 4.14158.9 ± 5.80
Week 4 Last Observation Carried Forward Mean141.9 ± 3.99162.9 ± 6.00
Adjusted Mean Change from Baseline-10.8 ± 2.844.5 ± 2.81
Statistical analysis
  • Saxagliptin 5 mg + Metformin vs Placebo + Metformin · ANCOVA · p = 0.0002 (Between-group comparisons significant at alpha = 0.05, significance testing based on hierarchical testing. Primary and secondary endpoints are presented in order of testing.) · Mean difference (final values): -15.3 · 95% CI -23.3 to -7.4Mean difference = adjusted mean change for saxagliptin 5 mg + Metformin - adjusted mean change for Placebo + Metformin

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
PLACEBO + MET—0/47 (0%)5/47 (10.6%)
SAXA 5MG + MET—0/46 (0%)1/46 (2.2%)
Most frequent other events
Most frequent other events
EventPLACEBO + METSAXA 5MG + MET
HEADACHENervous system disorders3/471/46
NAUSEAGastrointestinal disorders3/470/46

Baseline characteristics

Age, Continuous
Age, Continuous(years)Saxagliptin 5 mg + MetforminPlacebo + MetforminTotal
Mean54.50 ± 9.2055.77 ± 9.1455.14 ± 9.14
Age, Customized
Age, Customized(participants)Saxagliptin 5 mg + MetforminPlacebo + MetforminTotal
<65 years403878
>= 65 years to <75 years6814
>= 75 years011
Sex: Female, Male
Sex: Female, Male(Participants)Saxagliptin 5 mg + MetforminPlacebo + MetforminTotal
Female202444
Male262349
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Saxagliptin 5 mg + MetforminPlacebo + MetforminTotal
White394382
Black/African American325
Asian213
Other213
08

Study locations

27 sites
  • Dedicated Phase I, Inc.
    Phoenix, Arizona 85013, United States
  • Amcr Institute, Inc
    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
    Martinez, Buenos Aires B1640AOD, Argentina
  • Local Institution
    Holon, 58100, Israel
  • Local Institution
    Jerusalem, 91120, Israel
  • Local Institution
    Kfar-Saba, 44281, Israel
  • Local Institution
    Zerifin, 70300, Israel
  • Local Institution
    Milano, 20132, Italy
  • Local Institution
    Monterrey, Nuevo Leon 64460, Mexico
  • Local Institution
    Aguascalientes, 20230, Mexico
  • Local Institution
    Cebu City, 6000, Philippines
  • Local Institution
    Marikina City, 1800, Philippines
  • Local Institution
    Ponce, 00717, Puerto Rico
  • Local Institution
    Gothenburg, 413 45, Sweden
  • Local Institution
    Huddinge, 141 86, Sweden
  • Local Institution
    Lund, 221 85, Sweden
09

References and documents

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00683657
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
May 23, 2008
Start date
Jul 2008
Primary completion
Feb 2009
Completion
Feb 2009
Results posted
Mar 10, 2010
Last update
Jun 1, 2015

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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