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CompletedNCT00698932Updated Sep 21, 2011Results posted

Evaluate Efficacy and Safety of Saxagliptin in Adult Patients With Type 2 Diabetes Inadequate Glycemic Control

A Phase 3 interventional study of Saxagliptin and Placebo in Type 2 Diabetes, sponsored by AstraZeneca. Completed at 30 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-09-21.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
568
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 with inadequate glycaemic control with 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 568 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
  • Patients should be drug naïve ie, not received medical treatment for diabetes,
  • HbA1c ≥ 7.2% and ≤10.0% (at enrolment), HbA1c ≥ 7.0% and ≤10.0% (at randomization)

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
568 participants (actual)

Study arms

  • Experimental
    Saxagliptin 5mg

    Drug: Saxagliptin

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugSaxagliptin

    5mg, oral tablet, once daily for 24 weeks

    Also known as: Onglyza

  • DrugPlacebo

    oral tablet, once daily for 24 weeks

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 versus placebo 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. HbA1c data were excluded on and after rescue medication.

    Time frame: Baseline , Week 24

Secondary outcomes

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

    Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (Last Observation Carried Forward (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. FPG data were excluded on and after rescue medication.

    Time frame: Baseline, Week 24

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

    Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo 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. FPG data were excluded on and after rescue medication.

    Time frame: Baseline, Week 24

  3. Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants

    Adjusted\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication

    Time frame: Baseline , Week 24

  4. Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants

    Adjusted\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication

    Time frame: Baseline , Week 24

  5. Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24

    Proportion of participants (expressed in percentage of total participants) achieving HbA1c \< 7.0% for saxagliptin versus placebo at week 24. HbA1c Data were excluded on and after rescue medication

    Time frame: Baseline, Week 24

07

Results

Posted Sep 21, 2011

Participant flow

Participant flow — Overall Study
MilestoneSaxagliptin 5 mgPlacebo
Started284284
Completed262248
Not completed2236
Withdrew: Adverse event02
Withdrew: Incorrect enrollment02
Withdrew: Study specific discontinuation criteria34
Withdrew: Withdrawal by subject1123
Withdrew: Lost to follow-up61
Withdrew: Severe non-compliance to protocol12
Withdrew: Safety reasons02
Withdrew: Death10

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 versus placebo 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. HbA1c data were excluded on and after rescue medication.

Time frame:
Baseline , Week 24
Reported as:
Mean · percent
Absolute Change From Baseline to Week 24 in Glycosylated Haemoglobin A1c (HbA1c)
percentSaxagliptin 5 mgPlacebo
Baseline8.15 ± 0.0508.14 ± 0.050
Week 247.25 ± 0.0637.75 ± 0.076
Adjusted Mean Change from Baseline-0.84 ± 0.067-0.34 ± 0.065
Statistical analysis
  • Saxagliptin 5 mg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (net): -0.50 · 95% CI -0.65 to -0.34\*adjusted for baseline HbA1c
SecondaryAbsolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)

Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo at week 24 (Last Observation Carried Forward (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. FPG data were excluded on and after rescue medication.

Time frame:
Baseline, Week 24
Reported as:
Mean · mmol/L
Absolute Change (mmol/L) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
mmol/LSaxagliptin 5 mgPlacebo
Baseline9.15 ± 0.1259.05 ± 0.141
week 248.10 ± 0.1298.77 ± 0.163
Adjusted mean change from Baseline-0.90 ± 0.144-0.17 ± 0.141
Statistical analysis
  • Saxagliptin 5 mg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (net): -0.73 · 95% CI -1.06 to -0.39\*adjusted for baseline FPG
SecondaryAbsolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)

Adjusted\* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 5 mg versus placebo 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. FPG data were excluded on and after rescue medication.

Time frame:
Baseline, Week 24
Reported as:
Mean · mg/dL
Absolute Change (mg/dL) From Baseline to Week 24 in Fasting Plasma Glucose (FPG)
mg/dLSaxagliptin 5 mgPlacebo
Baseline164.85 ± 2.253163.03 ± 2.543
Week 24145.97 ± 2.317158.04 ± 2.942
Adjusted mean change from Baseline-16.13 ± 2.586-3.01 ± 2.544
Statistical analysis
  • Saxagliptin 5 mg vs Placebo · ANCOVA · p = <0.0001 · Mean difference (net): -13.12 · 95% CI -19.12 to -7.13\*adjusted for baseline FPG
SecondaryAbsolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants

Adjusted\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication

Time frame:
Baseline , Week 24
Reported as:
Mean · mmol*min/L
Absolute Change (mmol*Min/L) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants
mmol*min/LSaxagliptin 5 mgPlacebo
Baseline2474 ± 46.92506 ± 64.9
Week 242063 ± 41.12262 ± 57.6
Adjusted mean change from Baseline-417 ± 36.5-235 ± 40.4
Statistical analysis
  • Saxagliptin 5 mg vs Placebo · ANCOVA · p = 0.001 · Median difference (net): -182 · 95% CI -289 to -74\*adjusted for baseline PPG AUC
SecondaryAbsolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants

Adjusted\* mean change from baseline in PPG AUC achieved with saxagliptin 5 mg versus placebo at week 24 (LOCF, Full Analysis set). Trapezoidal method was used to compute AUC under the 3 hour PPG curve. Change from baseline for each subject is computed as the week 24 value minus the baseline value.PPG data were excluded on and after rescue medication

Time frame:
Baseline , Week 24
Reported as:
Mean · mg*min/dL
Absolute Change (mg*Min/dL) From Baseline to Week 24 in Area Under the Curve (AUC) From 0 to 180 Minutes for Postprandial Glucose (PPG) During Mixed Meal (Instant Noodles) Tolerance Tests (MMTT) in All MMTT Participants
mg*min/dLSaxagliptin 5 mgPlacebo
Baseline44586 ± 844.845146 ± 1170.5
week 2437166 ± 739.640751 ± 1036.6
Adjusted mean change from Baseline-7534 ± 657.4-4255 ± 726.4
Statistical analysis
  • Saxagliptin 5 mg vs Placebo · ANCOVA · p = 0.001 · Mean difference (net): -3280 · 95% CI -5214 to -1345\*adjusted for baseline PPG AUC
SecondaryProportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24

Proportion of participants (expressed in percentage of total participants) achieving HbA1c \< 7.0% for saxagliptin versus placebo at week 24. HbA1c Data were excluded on and after rescue medication

Time frame:
Baseline, Week 24
Reported as:
Number · Percentage of Participants
Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 24
Percentage of ParticipantsSaxagliptin 5 mgPlacebo
Proportion of Patients Achieving a Therapeutic Glycemic Response Defined as HbA1c <7.0% at Week 2445.828.8
Statistical analysis
  • Saxagliptin 5 mg vs Placebo · ANCOVA · p = <0.0001 · Median difference (net): 17.0 · 95% CI 8.9 to 24.9

Adverse events

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

Adverse event summary by group
GroupDeathsSeriousOther
Saxagliptin 5 mg—8/284 (2.8%)18/284 (6.3%)
Placebo—4/284 (1.4%)22/284 (7.7%)
Most frequent serious events
Showing 10 of 13
Most frequent serious events
EventSaxagliptin 5 mgPlacebo
Angina UnstableCardiac disorders2/2840/284
PneumoniaInfections and infestations0/2842/284
Myocardial InfarctionCardiac disorders1/2840/284
Intestinal ObstructionGastrointestinal disorders1/2840/284
Anal InjuryInjury, poisoning and procedural complications1/2840/284
OsteoarthritisMusculoskeletal and connective tissue disorders1/2840/284
Cerebrovascular AccidentNervous system disorders1/2840/284
Pleural EffusionRespiratory, thoracic and mediastinal disorders1/2840/284
AsthmaRespiratory, thoracic and mediastinal disorders0/2841/284
CellulitisInfections and infestations0/2841/284
Most frequent other events
Most frequent other events
EventSaxagliptin 5 mgPlacebo
Upper Respiratory Tract InfectionInfections and infestations18/28422/284

Baseline characteristics

Age Continuous
Age Continuous(Years)Saxagliptin 5 mgPlaceboTotal
Mean51.23 ± 10.0451.57 ± 10.3451.4 ± 10.18
Sex: Female, Male
Sex: Female, Male(Participants)Saxagliptin 5 mgPlaceboTotal
Female124129253
Male160155315
08

Study locations

30 sites
  • Research Site
    Hefei, Anhui, China
  • Research Site
    Fuzhou, Fujian, China
  • Research Site
    Guangzhou, Guangdong, China
  • Research Site
    Shijiazhuang, Hebei, 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
    Hyderabaad, Andhra Pradesh, India
  • Research Site
    Bangalore, Karnataka, India
  • Research Site
    Mangalore, Karnataka, India
  • Research Site
    Mumbai, Maharashtra, India
  • Research Site
    Nagpur, Maharashtra, India
  • Research Site
    Pune, Maharashtra, India
  • Research Site
    Coimbatore, India
  • Research Site
    Jeonju, Chonbuk, Korea, Republic of
  • Research Site
    Daegu, Korea, Republic of
  • Research Site
    Seoul, Korea, Republic of
  • Research Site
    Cebu City, Philippines
  • Research Site
    Makati City, Philippines
  • Research Site
    Manila, Philippines
  • Research Site
    Marikina City, Philippines
  • Research Site
    Quezon City, Philippines
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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 21, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00698932
Lead sponsor
AstraZeneca
Collaborators
Bristol-Myers Squibb
First posted
Jun 17, 2008
Start date
Jun 2008
Primary completion
Oct 2009
Completion
Oct 2009
Results posted
Sep 21, 2011
Last update
Sep 21, 2011

Study contacts

Peter Öhman, MD, PhD
study director · AstraZeneca, Wilmington, USA
Deborah Price, MSc
study chair · AstraZeneca, Wilmington, USA

Oversight

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

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