CompletedNCT01128153Updated Aug 10, 2012Results posted

Saxagliptin Triple Oral Therapy

A Phase 3 interventional study of Saxagliptin and Placebo in Type 2 Diabetes, sponsored by AstraZeneca. Completed at 33 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-10.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 257
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of this study is to determine whether the addition of saxagliptin to a patient's combination treatment of metformin and sulfonylurea for a 24 week period will provide better control of the patient's type 2 diabetes and will be well tolerated.

Read the detailed description

A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb Study to Evaluate Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects with Type 2 Diabetes who have Inadequate Glycaemic Control with Combination of Metformin and Sulfonylurea

Conditions studied

Type 2 Diabetes

Browse trials for

Diabetes Mellitus, Type 2 9,359

Keywords

Type 2 Diabetes
Inadequate Glycaemic Control
Saxagliptin
Metformin
Sulfonylurea
Triple Oral Therapy

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 257 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.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Written Informed Consent
Males or females with type 2 diabetes with inadequate glycaemic control (HbA1c > or = 7% and \< or = 10%) despite being on combination of metformin and sulfonylurea for at least 8 weeks prior to Visit 1
BMI \< or = 40 kg/m2

Exclusion criteria

Exclusion Criteria:

Symptoms of poorly controlled diabetes including but not limited to marked polyuria and marked polydipsia with > 10% weight loss in 3 months prior to entry, or other signs and symptoms
History of diabetic ketoacidosis or hyperosmolar non-ketotic coma
Current or prior use within 3 months of Visit 1 of insulin, DDP4 inhibitor, GLP-1 analogues, and/or other oral anti-diabetic agents (other than metformin or sulfonylurea)
Treatment with CYP3A4 inducers and/or potent CYP3A4/5 inhibitor
Estimated CrCl \< 60 ml/min at Visit 2
CHF (NYHA class III or IV) and/or LVEF \<40%
Active liver disease and/or significant abnormal liver function defined as AST and/or ALT > 3 x ULN and/or bilirubin > 2.0 mg/dL at Visit 2.
Creatine kinase > or = 10 x ULN at Visit 2

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 257 participants (actual)

Study arms

Experimental
Saxagliptin 5 mg once daily
Drug: Saxagliptin
Placebo comparator
Placebo once daily
Drug: Placebo

Interventions

DrugSaxagliptin
5 mg tablet once daily for 24 weeks to be taken orally
Also known as: Onglyza
DrugPlacebo
tablet once daily for 24 weeks to be taken orally

What researchers measure

Primary outcomes

Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)
Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model
Time frame: From Baseline to Week 24 weeks

Secondary outcomes

Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model
Time frame: From Baseline to Week 24
Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model
Time frame: From Baseline to Week 24
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance
Time frame: From Baseline to Week 24
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model
Time frame: From Baseline to Week 24
Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)
Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24
Time frame: From Baseline to Week 24

Results

Posted Aug 3, 2012

Participant flow

Participants were recruited to the study from 35 centres in 6 countries (Australia, United Kingdom, Canada, Korea, India and Thailand). Participants were recruited between June 2010 and December 2010.

Participant flow — Overall Study
Milestone	SAXAGLIPTIN	PLACEBO
Started	129	128
Full analysis set	127	128
Completed	113	113
Not completed	16	15
Withdrew: Adverse event	1	3
Withdrew: Condition under investigation worsened	8	7
Withdrew: Withdrawal by subject	2	3
Withdrew: Incorrect enrolment to study	2	1
Withdrew: Protocol violation	2	0
Withdrew: Developed discontinuation criteria	1	1

Outcome measures

PrimaryChange in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)

Adjusted Mean Change in HbA1c from baseline to Week 24 using analysis of covariance model

Time frame:: From Baseline to Week 24 weeks
Reported as:: Mean · percent

Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)
percent	Arm 1 - SAXAGLIPTIN	Arm 2 - PLACEBO
Change in HbA1c From Baseline to Week 24, Last Observation Carried Forward (LOCF)	-0.74 (-0.89 to -0.60)	-0.08 (-0.23 to 0.07)

Statistical analysis

Arm 1 - SAXAGLIPTIN vs Arm 2 - PLACEBO · ANCOVA · p = <0.0001 · Mean difference (final values): -0.66 · 95% CI -0.86 to -0.47Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)

SecondaryChange in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]

Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model

Time frame:: From Baseline to Week 24
Reported as:: Mean · mg/dL

Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
mg/dL	Arm 1 - SAXAGLIPTIN	Arm 2 - PLACEBO
Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]	-11.66 (-23.38 to 0.07)	5.08 (-6.45 to 16.60)

Statistical analysis

Arm 1 - SAXAGLIPTIN vs Arm 2 - PLACEBO · ANCOVA · p = 0.0301 · Mean difference (final values): -16.74 · 95% CI -31.85 to -1.62Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)

SecondaryChange in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]

Adjusted Mean Change in 2-hour PPG from baseline to Week 24 using analysis of covariance model

Time frame:: From Baseline to Week 24
Reported as:: Mean · mmol/L

Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
mmol/L	Arm 1 - SAXAGLIPTIN	Arm 2 - PLACEBO
Change in 2-hour Postprandial Glucose (PPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]	-0.65 (-1.30 to 0.00)	0.28 (-0.36 to 0.92)

Statistical analysis

Arm 1 - SAXAGLIPTIN vs Arm 2 - PLACEBO · ANCOVA · p = 0.0301 · Mean difference (final values): -0.93 · 95% CI -1.77 to -0.09Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)

SecondaryChange in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]

Adjusted Mean Change in fasting plasma glucose from baseline to Week 24 using analysis of covariance

Time frame:: From Baseline to Week 24
Reported as:: Mean · mg/dL

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]
mg/dL	Arm 1 - SAXAGLIPTIN	Arm 2 - PLACEBO
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mg/dL]	-5.28 (-12.67 to 2.11)	2.62 (-4.47 to 9.71)

Statistical analysis

Arm 1 - SAXAGLIPTIN vs Arm 2 - PLACEBO · ANCOVA · p = 0.0868 · Mean difference (final values): -7.90 · 95% CI -16.96 to 1.15Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)

SecondaryChange in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]

Adjusted Mean Change in FPG from baseline to Week 24 using analysis of covariance model

Time frame:: From Baseline to Week 24
Reported as:: Mean · mmol/L

Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]
mmol/L	Arm 1 - SAXAGLIPTIN	Arm 2 - PLACEBO
Change in Fasting Plasma Glucose (FPG) From Baseline to Week 24, Last Observation Carried Forward (LOCF) Measured as [mmol/L]	-0.29 (-0.70 to 0.12)	0.15 (-0.25 to 0.54)

Statistical analysis

Arm 1 - SAXAGLIPTIN vs Arm 2 - PLACEBO · ANCOVA · p = 0.0868 · Mean difference (final values): -0.44 · 95% CI -0.94 to 0.06Adjusted mean treatment difference from the ANCOVA model (Saxagliptin - Placebo)

SecondaryProportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)

Number of participants achieving a glycaemic response defined as HbA1c less than 7% at Week 24

Time frame:: From Baseline to Week 24
Reported as:: Number · Participants

Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)
Participants	Arm 1 - SAXAGLIPTIN	Arm 2 - PLACEBO
Proportion of Participants Achieving a Therapeutic Response: HbA1c Less Than 7% at Week 24, Last Observation Carried Forward (LOCF)	39	12

Statistical analysis

Arm 1 - SAXAGLIPTIN vs Arm 2 - PLACEBO · ANCOVA · p = <0.0001 · Odds ratio (or): 9.006 · 95% CI 3.852 to 21.05Estimated Odds Ratio from the logistic regression model (Saxa/Placebo)

Adverse events

Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
SAXAGLIPTIN	—	3/129 (2.3%)	53/129 (41.1%)
PLACEBO	—	7/128 (5.5%)	65/128 (50.8%)

Most frequent serious events

Showing 10 of 11

Most frequent serious events
Event	SAXAGLIPTIN	PLACEBO
InfluenzaInfections and infestations	0/129	1/128
OsteomyelitisInfections and infestations	0/129	1/128
Squamous Cell CarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/129	1/128
Cartilage InjuryInjury, poisoning and procedural complications	0/129	1/128
ArthritisMusculoskeletal and connective tissue disorders	0/129	1/128
Musculoskeletal StiffnessMusculoskeletal and connective tissue disorders	0/129	1/128
Renal ColicRenal and urinary disorders	0/129	1/128
AsthmaRespiratory, thoracic and mediastinal disorders	0/129	1/128
Lower Respiratory Tract InfectionInfections and infestations	1/129	0/128
Laryngeal CancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/129	0/128

Most frequent other events

Showing 10 of 23

Most frequent other events
Event	SAXAGLIPTIN	PLACEBO
NasopharyngitisInfections and infestations	8/129	12/128
Urinary Tract InfectionInfections and infestations	4/129	8/128
DyslipidaemiaMetabolism and nutrition disorders	5/129	7/128
DiarrhoeaGastrointestinal disorders	7/129	5/128
HypertensionVascular disorders	7/129	2/128
Upper Respiratory Tract InfectionInfections and infestations	6/129	6/128
AnaemiaBlood and lymphatic system disorders	1/129	5/128
NauseaGastrointestinal disorders	2/129	4/128
HyperglycaemiaMetabolism and nutrition disorders	4/129	4/128
Back PainMusculoskeletal and connective tissue disorders	1/129	4/128

Baseline characteristics

Age Continuous
Age Continuous(years)	SAXAGLIPTIN	PLACEBO	Total
Mean	57.2 ± 9.55	56.8 ± 11.49	57.0 ± 10.54

Sex: Female, Male
Sex: Female, Male(Participants)	SAXAGLIPTIN	PLACEBO	Total
Female	49	54	103
Male	80	74	154

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	SAXAGLIPTIN	PLACEBO	Total
White	59	57	116
Asian	70	71	141

Region of Enrollment
Region of Enrollment(Participants)	SAXAGLIPTIN	PLACEBO	Total
Australia	25	25	50
Canada	10	10	20
India	35	34	69
Korea, Republic of	25	24	49
Thailand	8	10	18
United Kingdom	26	25	51

BMI
BMI(kg/m2)	SAXAGLIPTIN	PLACEBO	Total
Mean	29.4 ± 5.26	29.1 ± 4.93	29.2 ± 5.09

HbA1c
HbA1c(%)	SAXAGLIPTIN	PLACEBO	Total
Mean	8.38 ± 0.856	8.19 ± 0.832	8.28 ± 0.848

2-hour Postprandial Glucose
2-hour Postprandial Glucose(mg/dL)	SAXAGLIPTIN	PLACEBO	Total
Mean	269.18 ± 76.814	265.6 ± 69.713	267.39 ± 73.220

2-hour Postprandial glucose
2-hour Postprandial glucose(mmol/L)	SAXAGLIPTIN	PLACEBO	Total
Mean	14.94 ± 4.263	14.74 ± 3.869	14.84 ± 4.064

2 further baseline measures are reported on the registry.

Study locations

33 sites

Research Site
Broadmeadow, New South Wales, Australia
Research Site
Wollongong, New South Wales, Australia
Research Site
Daw Park, South Australia, Australia
Research Site
Elizabeth Vale, South Australia, Australia
Research Site
Melbourne, Victoria, Australia
Research Site
Camperdown, Australia
Research Site
Herston, Australia
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Sydney Mines, Nova Scotia, Canada
Research Site
Thornhill, Ontario, Canada
Research Site
Kensington, Prince Edward Island, Canada
Research Site
Karnal, Haryana, India
Research Site
Bangalore, Karnataka, India
Research Site
Indore, Madhya Pradesh, India
Research Site
Pune, Maharashtra, India
Research Site
Coimbatore, Tamil Nadu, India
Research Site
Wonju, Kangwon-do, Korea, Republic of
Research Site
Goyang, Kyounggi-do, Korea, Republic of
Research Site
Daegu, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Research Site
Bangkok, Thailand
Research Site
Reading, Berks, United Kingdom
Research Site
ELY, Cambridgeshire, United Kingdom
Research Site
Whitstable, Kent, United Kingdom
Research Site
Westbury, Wiltshire, United Kingdom
Research Site
Ashford, United Kingdom
Research Site
Belfast, United Kingdom
Research Site
Blackpool, United Kingdom
Research Site
Chesterfield, United Kingdom
Research Site
Coventry, United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
Peterborough, United Kingdom
Research Site
Wellingborough, United Kingdom

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01128153
Lead sponsor: AstraZeneca
Collaborators: Bristol-Myers Squibb
Responsible party: Sponsor
First posted: May 21, 2010
Start date: Jun 2010
Primary completion: Jun 2011
Completion: Jun 2011
Results posted: Aug 3, 2012
Last update: Aug 10, 2012

Study contacts

Jayanti Visvanthan, MD

study chair · AstraZeneca

Simon Fisher, MD

study chair · AstraZeneca

Vinod Mattoo, MD

study chair · Bristol-Myers Squibb

Robert Moses, MBBS

principal investigator · Sydney Diabetes Centre

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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Saxagliptin Triple Oral Therapy

Study summary

Conditions studied

Browse trials for

Keywords

In context

Diabetes Mellitus, Type 2

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria