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CompletedNCT00661362Updated Mar 8, 2012Results posted

Evaluate Efficacy and Safety of Saxagliptin in Combination With Metformin in Adult Patients With Type 2 Diabetes

A Phase 3 interventional study of Saxagliptin and Placebo in Type 2 Diabetes, sponsored by AstraZeneca. Completed at 30 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-03-08.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
570
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Saxagliptin is a new investigational medication being developed for treatment of type 2 diabetes. This study is designed to evaluate the efficacy and safety in adult patients who have inadequate glycaemic control when treated with metformin in addition to diet and exercise.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • DPP-4 inhibitors
  • HbA1c
  • Incretins
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 570 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus 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 and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Diagnosed with Type 2 diabetes
  • Treatment with metformin at a stable dose >1500 mg/day
  • HbA1c ≥ 7.0% and ≤10.0%

Exclusion criteria

Exclusion Criteria:

  • Insulin therapy within one year of enrolment (with the exception of insulin therapy during a hospitalization or use in gestational diabetes)
  • Type 1 diabetes, history of ketoacidosis, or hyperosmolar non-ketonic koma
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
570 participants (actual)

Study arms

  • Experimental
    1

    Metformin + Saxagliptin

    Drug: Saxagliptin · Drug: Metformin

  • Placebo comparator
    2

    Metformin + Placebo

    Drug: Placebo · Drug: Metformin

Interventions

  • DrugSaxagliptin

    Oral tablet, once daily for 24 weeks

    Also known as: Onglyza

  • DrugPlacebo

    oral tablet, once daily for 24 weeks

  • DrugMetformin

    oral tablet, once daily for 24 weeks

    Also known as: Glucophage

06

What researchers measure

Primary outcomes

  1. Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)

    Adjusted\* mean change from baseline in HbA1c achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. \*Adjusted for baseline HbA1c.

    Time frame: Baseline , Week 24

Secondary outcomes

  1. Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L

    Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (Last Observation Carried Out (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. \*Adjusted for baseline FPG.

    Time frame: Baseline , Week 24

  2. Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL

    Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. \*Adjusted for baseline FPG.

    Time frame: Baseline , Week 24

  3. Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup

    Adjusted\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. \*Adjusted for baseline PPG AUC.

    Time frame: Baseline , Week 24

  4. Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup

    Adjusted\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo+metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. \*Adjusted for baseline PPG AUC.

    Time frame: Baseline , Week 24

  5. Proportion of Patients Achieving a Therapeutic Glycemic Response

    Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c \< 7.0% for saxagliptin + metformin versus placebo + metformin at week 24

    Time frame: Baseline , Week 24

07

Results

Posted Mar 8, 2012

Participant flow

Participant flow — Overall Study
MilestoneSaxagliptin 5 mg + MetforminPlacebo + Metformin
Started283287
Completed254247
Not completed2940
Withdrew: Adverse event54
Withdrew: Incorrect enrollment20
Withdrew: Study specific discontinuation criteria411
Withdrew: Withdrawal by subject1323
Withdrew: Lost to follow-up31
Withdrew: Severe non-compliance to protocol01
Withdrew: Safety reasons10
Withdrew: Metformin dose haven't decreasd to 2.5 g10

Outcome measures

PrimaryAbsolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)

Adjusted\* mean change from baseline in HbA1c achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). HbA1c is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. \*Adjusted for baseline HbA1c.

Time frame:
Baseline , Week 24
Reported as:
Mean · percent
Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
percentSaxagliptin 5 mg + MetforminPlacebo + Metformin
Baseline7.90 ± 0.0497.94 ± 0.050
Week 247.10 ± 0.0567.55 ± 0.062
adjusted baseline HbA1c-0.78 ± 0.051-0.37 ± 0.050
Statistical analysis
  • Saxagliptin 5 mg + Metformin vs Placebo + Metformin · ANCOVA · p = <0.0001 · Mean difference (net): -0.42 · 95% CI -0.55 to -0.29
SecondaryAbsolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L

Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (Last Observation Carried Out (LOCF), Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. \*Adjusted for baseline FPG.

Time frame:
Baseline , Week 24
Reported as:
Mean · mmol/L
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mmol/L
mmol/LSaxagliptin 5 mg + MetforminPlacebo + Metformin
Baseline8.57 ± 0.1178.87 ± 0.137
Week 247.61 ± 0.1178.30 ± 0.127
Adjusted Change from Baseline-1.14 ± 0.114-0.58 ± 0.111
Statistical analysis
  • Saxagliptin 5 mg + Metformin vs Placebo + Metformin · ANCOVA · p = <0.0002 · Mean difference (net): -0.56 · 95% CI -0.85 to -0.26
SecondaryAbsolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL

Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). FPG is a continuous measure, the change from baseline for each subject is calculated as the week 24 values minus the baseline value. \*Adjusted for baseline FPG.

Time frame:
Baseline , Week 24
Reported as:
Mean · mg/dL
Absolute Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) mg/dL
mg/dLSaxagliptin 5 mg + MetforminPlacebo + Metformin
Baseline154.54 ± 2.103159.73 ± 2.467
Week 24137.15 ± 2.116149.54 ± 2.286
Adjusted Change from Baseline-20.52 ± 2.051-10.42 ± 2.004
Statistical analysis
  • Saxagliptin 5 mg + Metformin vs Placebo + Metformin · ANCOVA · p = <0.0002 · Mean difference (net): -10.10 · 95% CI -15.37 to -4.83
SecondaryChange From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup

Adjusted\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo + metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. \*Adjusted for baseline PPG AUC.

Time frame:
Baseline , Week 24
Reported as:
Mean · mmol*min/L
Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup
mmol*min/LSaxagliptin 5 mg + MetforminPlacebo + Metformin
Baseline2355 ± 45.62427 ± 51.5
Week 242058 ± 44.42249 ± 46.9
Adjusted Change from Baseline-315 ± 38.6-160 ± 39.0
Statistical analysis
  • Saxagliptin 5 mg + Metformin vs Placebo + Metformin · ANCOVA · p = 0.0052 · Mean difference (net): -155 · 95% CI -264 to -47
SecondaryChange From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup

Adjusted\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg + metformin versus placebo+metformin at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. The change from baseline for each subject is calculated as the week 24 value minus the baseline value. \*Adjusted for baseline PPG AUC.

Time frame:
Baseline , Week 24
Reported as:
Mean · mg*min/dL
Change From Baseline in the Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During a Mixed Meal Tolerance Test (MMTT) in a Subgroup
mg*min/dLSaxagliptin 5 mg + MetforminPlacebo + Metformin
Baseline42423 ± 821.943719 ± 927.3
Week 2437071 ± 799.440521 ± 845.7
Adjusted Change from Baseline-5673 ± 695.9-2871 ± 702.1
Statistical analysis
  • Saxagliptin 5 mg + Metformin vs Placebo + Metformin · ANCOVA · p = 0.0052 · Mean difference (net): -2802 · 95% CI -4753 to -852
SecondaryProportion of Patients Achieving a Therapeutic Glycemic Response

Proportion of participants achieving a therapeutic glycemic response, defined as having HbA1c \< 7.0% for saxagliptin + metformin versus placebo + metformin at week 24

Time frame:
Baseline , Week 24
Reported as:
Number · Percentage of participants
Proportion of Patients Achieving a Therapeutic Glycemic Response
Percentage of participantsSaxagliptin 5 mg + MetforminPlacebo + Metformin
Proportion of Patients Achieving a Therapeutic Glycemic Response46.530.5
Statistical analysis
  • Saxagliptin 5 mg + Metformin vs Placebo + Metformin · ANCOVA · p = <0.0001 · Mean difference (net): 16.1 · 95% CI 8.0 to 24.0

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Saxagliptin 5 mg + Metformin—8/283 (2.8%)19/283 (6.7%)
Placebo + Metformin—3/287 (1%)13/287 (4.5%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventSaxagliptin 5 mg + MetforminPlacebo + Metformin
Anal AbscessInfections and infestations1/2830/287
AppendicitisInfections and infestations1/2830/287
Hepatitis BInfections and infestations1/2830/287
Pulmonary TuberculosisInfections and infestations1/2830/287
Ankle FractureInjury, poisoning and procedural complications1/2830/287
Clavicle FractureInjury, poisoning and procedural complications1/2830/287
Rib FractureInjury, poisoning and procedural complications1/2830/287
Cholecystitis AcuteHepatobiliary disorders1/2830/287
Cerebral InfarctionNervous system disorders1/2831/287
Urinary Tract InfectionInfections and infestations0/2831/287
Most frequent other events
Most frequent other events
EventSaxagliptin 5 mg + MetforminPlacebo + Metformin
Upper Respiratory Tract InfectionInfections and infestations19/28313/287

Baseline characteristics

Age Continuous
Age Continuous(Years)Saxagliptin 5 mg + MetforminPlacebo + MetforminTotal
Mean53.75 ± 10.4254.36 ± 10.0654.05 ± 10.24
Sex: Female, Male
Sex: Female, Male(Participants)Saxagliptin 5 mg + MetforminPlacebo + MetforminTotal
Female147148295
Male136139275
08

Study locations

30 sites
  • Research Site
    Hefei, Anhui, China
  • Research Site
    Guangzhou, Guangdong, China
  • Research Site
    Shi Jiazhuang, Hebei, China
  • Research Site
    Ha'er Bing, Hei Longjiang, China
  • Research Site
    Wuhan, Hu Bei, China
  • Research Site
    Changsha, Hunan, China
  • Research Site
    Nanjing, Jiangsu, China
  • Research Site
    Changchun, Jilin, China
  • Research Site
    Dalian, Liaoning, China
  • Research Site
    Shenyang, Liaoning, China
  • Research Site
    Shanghai, Shanghai, China
  • Research Site
    Chengdu, Sichuan, China
  • Research Site
    Hangzhou, Zhejiang, China
  • Research Site
    Beijing, China
  • Research Site
    Chongqing, China
  • Research Site
    Tianjin, China
  • Research Site
    Hyderabad, Andhra Pradesh, India
  • Research Site
    Bangalore, Karnataka, India
  • Research Site
    Mangalore, Karnataka, India
  • Research Site
    Nagpur, Maharashtra, India
  • Research Site
    Bangalore, India
  • Research Site
    Seongnam, Gyeonggi-do, Korea, Republic of
  • Research Site
    Bucheon, Korea, Republic of
  • Research Site
    Daegu, Korea, Republic of
  • Research Site
    Goyang, Korea, Republic of
  • Research Site
    Gwangju, Korea, Republic of
  • Research Site
    Incheon, Korea, Republic of
  • Research Site
    Pusan, Korea, Republic of
  • Research Site
    Seoul, Korea, Republic of
  • Research Site
    Uijeongbu-si, Korea, Republic of
09

References and documents

Publications

  • Perl S, Cook W, Wei C, Iqbal N, Hirshberg B. Saxagliptin Efficacy and Safety in Patients With Type 2 Diabetes and Moderate Renal Impairment. Diabetes Ther. 2016 Sep;7(3):527-35. doi: 10.1007/s13300-016-0184-9. Epub 2016 Jul 11. PubMed 27402391 ↗
  • Yang W, Pan CY, Tou C, Zhao J, Gause-Nilsson I. Efficacy and safety of saxagliptin added to metformin in Asian people with type 2 diabetes mellitus: a randomized controlled trial. Diabetes Res Clin Pract. 2011 Nov;94(2):217-24. doi: 10.1016/j.diabres.2011.07.035. Epub 2011 Aug 26. PubMed 21871686 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 8, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00661362
Lead sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Apr 18, 2008
Start date
Jun 2008
Primary completion
Sep 2009
Completion
Sep 2009
Results posted
Mar 8, 2012
Last update
Mar 8, 2012

Study contacts

Peter Ohman, MD
study director · AstraZeneca
Deborah Price, MSc
study chair · AstraZeneca

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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