Trial Outcomes & Findings for Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment (NCT NCT00614939)

NCT ID: NCT00614939

Last Updated: 2011-05-19

Results Overview

Adjusted\* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 572 participants
• Primary outcome timeframe: Baseline , Week 12 (LOCF)
• Results posted on: 2011-05-19

Participant Flow

A total of 572 participants were enrolled in the study; 561 entered the Lead-in period and 170 patients were randomized and treated.

Participant milestones

Measure	Placebo Placebo	Saxa Saxagliptin 2.5 mg once daily oral dose
Overall Study STARTED	85	85
Overall Study COMPLETED	50	42
Overall Study NOT COMPLETED	35	43

Reasons for withdrawal

Measure	Placebo Placebo	Saxa Saxagliptin 2.5 mg once daily oral dose
Overall Study Withdrawal by Subject	10	17
Overall Study Study specific discontinuation criteris	13	16
Overall Study Adverse Event	2	5
Overall Study Incorrect enrollment	1	2
Overall Study Death	4	3
Overall Study Poor/non-compliance	4	0
Overall Study Hospitalized due to kidney transplant	1	0

Baseline Characteristics

Treatment Effect of Saxagliptin Compared With Placebo in Patients With Type 2 Diabetes and Renal Impairment

Baseline characteristics by cohort

Measure	Placebo n=85 Participants Placebo	Saxa n=85 Participants Saxagliptin 2.5 mg once daily oral dose	Total n=170 Participants Total of all reporting groups
Age Continuous	66.2 years STANDARD_DEVIATION 9.08 • n=5 Participants	66.8 years STANDARD_DEVIATION 8.27 • n=7 Participants	66.5 years STANDARD_DEVIATION 8.66 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	53 Participants n=7 Participants	97 Participants n=5 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	32 Participants n=7 Participants	73 Participants n=5 Participants
Baseline Renal Impairment Category Moderate	42 Participants n=5 Participants	48 Participants n=7 Participants	90 Participants n=5 Participants
Baseline Renal Impairment Category Severe	23 Participants n=5 Participants	18 Participants n=7 Participants	41 Participants n=5 Participants
Baseline Renal Impairment Category End-Stage	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Baseline Diabetes Therapy Diabetes Therapy	84 participants n=5 Participants	83 participants n=7 Participants	167 participants n=5 Participants
Baseline Diabetes Therapy Insulin	57 participants n=5 Participants	71 participants n=7 Participants	128 participants n=5 Participants
Baseline Diabetes Therapy Oral blood glucose lowering drug	30 participants n=5 Participants	23 participants n=7 Participants	53 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline , Week 12 (LOCF)

Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.

Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.

Outcome measures

Measure	Placebo n=83 Participants Placebo	Saxa n=81 Participants Saxagliptin 2.5 mg once daily oral dose
Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF) Baseline	8.09 Percent Standard Error 0.119	8.45 Percent Standard Error 0.135
Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF) Week 12	7.80 Percent Standard Error 0.137	7.63 Percent Standard Error 0.132
Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 12 Last Observation Carried Forward (LOCF) Adjusted Mean Change from Baseline	-0.44 Percent Standard Error 0.109	-0.86 Percent Standard Error 0.112

SECONDARY outcome

Timeframe: Baseline, Week 12 (LOCF)

Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.

Outcome measures

Measure	Placebo n=40 Participants Placebo	Saxa n=44 Participants Saxagliptin 2.5 mg once daily oral dose
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup Baseline	162.33 mg/dL Standard Error 8.933	202.82 mg/dL Standard Error 9.858
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup Week 12	174.50 mg/dL Standard Error 10.089	173.91 mg/dL Standard Error 7.938
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF)- Moderate Renal Impairment Subgroup Adjusted Mean Change from Baseline	-2.88 mg/dL Standard Error 9.073	-15.22 mg/dL Standard Error 8.630

SECONDARY outcome

Timeframe: Baseline, Week 12 (LOCF)

Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.

Outcome measures

Measure	Placebo n=23 Participants Placebo	Saxa n=18 Participants Saxagliptin 2.5 mg once daily oral dose
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup Baseline	173.48 mg/dL Standard Error 11.630	165.50 mg/dL Standard Error 19.909
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup Week 12	141.52 mg/dL Standard Error 14.276	133.83 mg/dL Standard Error 11.371
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup Adjusted mean change	-29.91 mg/dL Standard Error 11.212	-34.28 mg/dL Standard Error 12.677

SECONDARY outcome

Timeframe: Baseline, Week 12 (LOCF)

Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.

Outcome measures

Measure	Placebo n=18 Participants Placebo	Saxa n=15 Participants Saxagliptin 2.5 mg once daily oral dose
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup Baseline	170.39 mg/dL Standard Error 14.518	177.07 mg/dL Standard Error 10.638
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup Week 12	161.11 mg/dL Standard Error 12.624	207.60 mg/dL Standard Error 30.515
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup Adjusted mean change	-11.18 mg/dL Standard Error 20.752	32.82 mg/dL Standard Error 22.737

SECONDARY outcome

Timeframe: Baseline, Week 12 (LOCF)

Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.

Outcome measures

Measure	Placebo n=40 Participants Placebo	Saxa n=44 Participants Saxagliptin 2.5 mg once daily oral dose
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup Baseline	9.01 mmol/L Standard Error 0.495	11.25 mmol/L Standard Error 0.548
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup Week 12	9.68 mmol/L Standard Error 0.560	9.65 mmol/L Standard Error 0.441
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Moderate Renal Impairment Subgroup Absolute mean change	-0.16 mmol/L Standard Error 0.504	-0.84 mmol/L Standard Error 0.479

SECONDARY outcome

Timeframe: Baseline, Week 12 (LOCF)

Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.

Outcome measures

Measure	Placebo n=23 Participants Placebo	Saxa n=18 Participants Saxagliptin 2.5 mg once daily oral dose
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup Baseline	9.63 mmol/L Standard Error 0.646	9.17 mmol/L Standard Error 1.105
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup Week 12	7.86 mmol/L Standard Error 0.793	7.43 mmol/L Standard Error 0.632
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - Severe Renal Impairment Subgroup Adjusted mean change	-1.66 mmol/L Standard Error 0.623	-1.89 mmol/L Standard Error 0.704

SECONDARY outcome

Timeframe: Baseline, Week 12 (LOCF)

Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 12 (LOCF) for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement.

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 12 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 12 value minus the baseline value.

Outcome measures

Measure	Placebo n=18 Participants Placebo	Saxa n=15 Participants Saxagliptin 2.5 mg once daily oral dose
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup Baseline	9.46 mmol/L Standard Error 0.807	9.83 mmol/L Standard Error 0.591
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup Week 12	8.94 mmol/L Standard Error 0.700	11.52 mmol/L Standard Error 1.692
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 12 (LOCF) - End-Stage Renal Impairment Subgroup Adjusted mean change	-0.62 mmol/L Standard Error 1.151	1.81 mmol/L Standard Error 1.261

SECONDARY outcome

Timeframe: Baseline , Week 52

Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.

Adjusted* mean change from baseline in HbA1c achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set). HbA1c is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.

Outcome measures

Measure	Placebo n=82 Participants Placebo	Saxa n=78 Participants Saxagliptin 2.5 mg once daily oral dose
Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52 Baseline	8.10 Percent Standard Error 0.120	8.44 Percent Standard Error 0.134
Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52 Week 52	7.93 Percent Standard Error 0.173	7.41 Percent Standard Error 0.138
Absolute Change From Baseline in Glycosylated Haemoglobin A1c (HbA1c) Level to Week 52 Adjusted mean change	-0.53 Percent Standard Error 0.154	-1.35 Percent Standard Error 0.174

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.

Outcome measures

Measure	Placebo n=40 Participants Placebo	Saxa n=44 Participants Saxagliptin 2.5 mg once daily oral dose
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup Baseline	162.33 mg/dL Standard Error 8.933	202.82 mg/dL Standard Error 9.858
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup Week 52	174.83 mg/dL Standard Error 11.295	177.43 mg/dL Standard Error 7.637
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup Adjusted mean change	3.02 mg/dL Standard Error 13.277	-14.96 mg/dL Standard Error 12.873

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.

Outcome measures

Measure	Placebo n=23 Participants Placebo	Saxa n=18 Participants Saxagliptin 2.5 mg once daily oral dose
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup Baseline	173.48 mg/dL Standard Error 11.630	165.50 mg/dL Standard Error 19.909
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup Week 52	151.78 mg/dL Standard Error 9.896	139.06 mg/dL Standard Error 12.408
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup Adjusted mean change	-24.59 mg/dL Standard Error 14.510	-40.32 mg/dL Standard Error 20.789

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.

Outcome measures

Measure	Placebo n=18 Participants Placebo	Saxa n=15 Participants Saxagliptin 2.5 mg once daily oral dose
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup Baseline	170.39 mg/dL Standard Error 14.518	177.07 mg/dL Standard Error 10.638
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup Week 52	161.94 mg/dL Standard Error 13.097	214.27 mg/dL Standard Error 31.740
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup Adjusted mean change	-2.18 mg/dL Standard Error 29.226	-40.28 mg/dL Standard Error 45.470

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the moderate renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value

Outcome measures

Measure	Placebo n=40 Participants Placebo	Saxa n=44 Participants Saxagliptin 2.5 mg once daily oral dose
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup Baseline	9.01 mmol/L Standard Error 0.495	11.25 mmol/L Standard Error 0.548
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup Week 52	9.70 mmol/L Standard Error 0.627	9.85 mmol/L Standard Error 0.424
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Moderate Renal Impairment Subgroup Adjusted mean change	0.15 mmol/L Standard Error 0.738	-0.82 mmol/L Standard Error 0.715

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the severe renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.

Outcome measures

Measure	Placebo n=23 Participants Placebo	Saxa n=18 Participants Saxagliptin 2.5 mg once daily oral dose
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup Baseline	9.63 mmol/L Standard Error 0.646	9.17 mmol/L Standard Error 1.105
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup Week 52	8.42 mmol/L Standard Error 0.551	7.71 mmol/L Standard Error 0.688
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - Severe Renal Impairment Subgroup Adjusted mean change	-1.37 mmol/L Standard Error 0.805	-2.25 mmol/L Standard Error 1.154

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Randomized participants who took at least 1 dose of double-blind treatment. To be included in analysis: change from baseline to Week 52 for efficacy, subjects must have had a baseline and at least 1 post-baseline efficacy measurement. Data were excluded after changes in oral blood glucose lowering drug or insulin.

Adjusted* mean change from baseline in fasting plasma glucose (FPG) achieved with saxagliptin 2.5 mg once daily versus placebo at Week 52 (Full Analysis Set) for the end-stage renal impairment subgroup. FPG is a continuous measure, the change from baseline for each participant is calculated at the Week 52 value minus the baseline value.

Outcome measures

Measure	Placebo n=18 Participants Placebo	Saxa n=15 Participants Saxagliptin 2.5 mg once daily oral dose
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup Baseline	9.46 mmol/L Standard Error 0.807	9.83 mmol/L Standard Error 0.591
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup Week 52	8.99 mmol/L Standard Error 0.728	11.89 mmol/L Standard Error 1.760
Absolute Change From Baseline in Fasting Plasma Glucose (FPG) to Week 52 - End-Stage Renal Impairment Subgroup Adjusted mean change	-0.11 mmol/L Standard Error 1.621	-2.25 mmol/L Standard Error 2.522

Adverse Events

Placebo

Serious events: 24 serious events

Other events: 36 other events

Deaths: 0 deaths

Saxa

Serious events: 23 serious events

Other events: 38 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=85 participants at risk Placebo	Saxa n=85 participants at risk Saxagliptin 2.5 mg once daily oral dose
Cardiac disorders Cardiac Failure Congestive	0.00% 0/85	1.2% 1/85
Cardiac disorders Myocardial Infarction	1.2% 1/85	2.4% 2/85
Gastrointestinal disorders Abdominal Pain Upper	0.00% 0/85	1.2% 1/85
Gastrointestinal disorders Diarrhoea	0.00% 0/85	1.2% 1/85
Infections and infestations Cystitis	0.00% 0/85	1.2% 1/85
Infections and infestations Urinary Tract Infection	0.00% 0/85	1.2% 1/85
Infections and infestations Pyelonephritis Acute	1.2% 1/85	1.2% 1/85
Infections and infestations Urosepsis	1.2% 1/85	0.00% 0/85
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/85	1.2% 1/85
Respiratory, thoracic and mediastinal disorders Interstitial Lung Disease	0.00% 0/85	1.2% 1/85
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/85	1.2% 1/85
Vascular disorders Hypertension	0.00% 0/85	1.2% 1/85
Vascular disorders Poor Peripheral Circulation	0.00% 0/85	1.2% 1/85
Vascular disorders Hypertensive crisis	1.2% 1/85	0.00% 0/85
Vascular disorders Peripheral Arterial Occlusive Disease	1.2% 1/85	0.00% 0/85
General disorders Oedema Peripheral	0.00% 0/85	1.2% 1/85
Investigations Alanine Aminotransferase Increased	0.00% 0/85	1.2% 1/85
Investigations Aspartate Aminotransferase Increased	0.00% 0/85	1.2% 1/85
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant Fibrous Histiocytoma	0.00% 0/85	1.2% 1/85
Renal and urinary disorders Renal Impairment	1.2% 1/85	1.2% 1/85
Injury, poisoning and procedural complications Upper Limb Fracture	1.2% 1/85	0.00% 0/85
Metabolism and nutrition disorders Diabetes Mellitus	1.2% 1/85	0.00% 0/85
Metabolism and nutrition disorders Hypoglycaemia	2.4% 2/85	0.00% 0/85
Infections and infestations Pneumonia	0.00% 0/85	2.4% 2/85
Infections and infestations Cellulitis	0.00% 0/85	1.2% 1/85
Infections and infestations Gangrene	1.2% 1/85	1.2% 1/85
Infections and infestations Pyelonephritis	0.00% 0/85	1.2% 1/85
Infections and infestations Infected Skin Ulcer	1.2% 1/85	0.00% 0/85
Infections and infestations Lobar Pneumonia	1.2% 1/85	0.00% 0/85
Infections and infestations Osteomyelitis	1.2% 1/85	0.00% 0/85
Infections and infestations Sepsis	1.2% 1/85	0.00% 0/85
Cardiac disorders Acute Myocardial Infarction	0.00% 0/85	1.2% 1/85
Cardiac disorders Cardiac Arrest	0.00% 0/85	1.2% 1/85
Cardiac disorders Atrial Fibrillation	1.2% 1/85	0.00% 0/85
Cardiac disorders Bifascicular Block	1.2% 1/85	0.00% 0/85
Cardiac disorders Cardiac Failure	2.4% 2/85	0.00% 0/85
Gastrointestinal disorders Gastrointestinal Haemorrhage	0.00% 0/85	1.2% 1/85
Gastrointestinal disorders Pancreatitis	1.2% 1/85	0.00% 0/85
Nervous system disorders Cauda Equina Syndrome	0.00% 0/85	1.2% 1/85
Nervous system disorders Cerebrovascular Accident	1.2% 1/85	1.2% 1/85
Nervous system disorders Dizziness	0.00% 0/85	1.2% 1/85
Nervous system disorders Cerebral Hypoperfusion	1.2% 1/85	0.00% 0/85
Vascular disorders Arteriovenous Fistula	0.00% 0/85	1.2% 1/85
Vascular disorders Orthostatic Hypotension	0.00% 0/85	1.2% 1/85
Vascular disorders Arteriosclerosis	1.2% 1/85	0.00% 0/85
Vascular disorders Femoral Artery Occlusion	1.2% 1/85	0.00% 0/85
Vascular disorders Peripheral Ischaemia	1.2% 1/85	0.00% 0/85
Eye disorders Cataract	0.00% 0/85	1.2% 1/85
Eye disorders Iridocyclitis	0.00% 0/85	1.2% 1/85
Eye disorders Pseudoexfoliation Of Lens Capsule	0.00% 0/85	1.2% 1/85
General disorders Sudden Death	2.4% 2/85	1.2% 1/85
Gastrointestinal disorders Oedema	1.2% 1/85	0.00% 0/85
Investigations Blood Glucose Increased	0.00% 0/85	1.2% 1/85
Renal and urinary disorders Calculus Ureteric	0.00% 0/85	1.2% 1/85
Renal and urinary disorders Renal Failure Chronic	1.2% 1/85	0.00% 0/85
Metabolism and nutrition disorders Diabetes Mellitus Inadequate Control	1.2% 1/85	1.2% 1/85
Metabolism and nutrition disorders Hyperglycaemia	1.2% 1/85	0.00% 0/85
Skin and subcutaneous tissue disorders Skin Ulcer	0.00% 0/85	1.2% 1/85
Skin and subcutaneous tissue disorders Skin Disorder	1.2% 1/85	0.00% 0/85
Injury, poisoning and procedural complications Arteriovenous Fistula Thrombosis	1.2% 1/85	0.00% 0/85
Injury, poisoning and procedural complications Wound	1.2% 1/85	0.00% 0/85
Musculoskeletal and connective tissue disorders Osteochondrosis	1.2% 1/85	0.00% 0/85
Injury, poisoning and procedural complications Arteriovenous Fistula Operation	1.2% 1/85	0.00% 0/85

Other adverse events

Measure	Placebo n=85 participants at risk Placebo	Saxa n=85 participants at risk Saxagliptin 2.5 mg once daily oral dose
Metabolism and nutrition disorders Hypoglycaemia	29.4% 25/85	28.2% 24/85
Blood and lymphatic system disorders Anaemia	8.2% 7/85	5.9% 5/85
General disorders Oedema Peripheral	7.1% 6/85	2.4% 2/85
Infections and infestations Urinary Tract Infection	3.5% 3/85	5.9% 5/85
Vascular disorders Hypertension	5.9% 5/85	5.9% 5/85

Additional Information

Gerard Lynch

AstraZeneca

Email: aztrial_results_posting@astrazeneca.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place