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Insulin Glargine Injection Treatment in Place of Thiazolidinedione (TZD), Sulfonylurea, or Metformin in Triple Agent Therapy for Type 2 Diabetes Mellitus (T2DM) Adult Subjects With Unsatisfactory Control

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ClinicalTrials.gov Identifier: NCT00283049
Recruitment Status : Terminated (Due to technical issues relating to the Electronic diary data.)
First Posted : January 27, 2006
Results First Posted : February 19, 2010
Last Update Posted : January 13, 2011
Sponsor:
Information provided by:
Sanofi

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes Mellitus, Type 2
Interventions Drug: Insulin Glargine
Drug: Insulin Glulisine
Enrollment 390
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
Hide Arm/Group Description Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Period Title: Overall Study
Started 128 [1] 128 [2] 130 [2]
Completed 70 83 76
Not Completed 58 45 54
Reason Not Completed
Adverse Event             6             1             4
Protocol Violation             3             0             3
Death             1             1             1
Lack of Efficacy             0             1             1
Lost to Follow-up             4             2             5
Withdrawal by Subject             26             24             19
Discontinuation of Study             18             16             20
No longer requires study treatment             0             0             1
[1]
2 randomized patients did not receive study drug and were not included in the safety population
[2]
1 randomized patient did not receive study drug and was not included in the safety population
Arm/Group Title SU + TZD + IG MET + TZD + IG MET+SU + IG Total
Hide Arm/Group Description Arm 1: Insulin glargine(IG) administered subcutaneously once daily plus a sulfonylurea and a thiazolidinedione(TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%) Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a thiazolidinedione (TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%) Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%) Total of all reporting groups
Overall Number of Baseline Participants 128 128 130 386
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants 128 participants 130 participants 386 participants
56.1  (9.57) 54.7  (10.14) 54.6  (9.41) 55.2  (9.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 128 participants 128 participants 130 participants 386 participants
Female
51
  39.8%
54
  42.2%
52
  40.0%
157
  40.7%
Male
77
  60.2%
74
  57.8%
78
  60.0%
229
  59.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
USA Number Analyzed 128 participants 128 participants 130 participants 386 participants
128 128 130 386
Body Mass Index (BMI)  
Mean (Standard Deviation)
Unit of measure:  Kg/m²
Number Analyzed 128 participants 128 participants 130 participants 386 participants
33.2  (6.41) 34.3  (6.57) 34.5  (7.04) 34.0  (6.69)
Duration of diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 128 participants 128 participants 130 participants 386 participants
10.5  (6.95) 9.7  (5.68) 10.5  (6.00) 10.2  (6.23)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 128 participants 128 participants 130 participants 386 participants
98.1  (21.46) 99.6  (20.22) 101.2  (24.98) 99.6  (22.31)
1.Primary Outcome
Title Change in Hemoglobin A1c (HbA1c) From Baseline to Week 12
Hide Description [Not Specified]
Time Frame 12 weeks from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population (excluding patients from Good Clinical Practice [GCP] non-compliant sites)
Arm/Group Title Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
Hide Arm/Group Description:
Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Overall Number of Participants Analyzed 116 111 120
Mean (Standard Deviation)
Unit of Measure: Percentage
-1.2  (1.72) -1.2  (1.35) -1.2  (1.31)
2.Secondary Outcome
Title Change From Baseline to Individual Time Points in HbA1c, Insulin Doses, and Total Insulin Dosage
Hide Description [Not Specified]
Time Frame 60 weeks from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.
Arm/Group Title Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
Hide Arm/Group Description:
Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Percentage of Subjects Achieving an HbA1C Less Than (<) 7.0% and Less Than (<) 6.5%
Hide Description [Not Specified]
Time Frame 60 weeks from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.
Arm/Group Title Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
Hide Arm/Group Description:
Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline to Study Time Points in 7-point Blood Glucose (BG) Profile (Before Meals, 2 Hours After Meals, at Bedtime)
Hide Description [Not Specified]
Time Frame 60 weeks from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.
Arm/Group Title Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
Hide Arm/Group Description:
Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Change From Baseline to End of Study and to Individual Time Points in Components of Lipid Profile (Total Cholesterol, High-density Lipoprotein Cholesterol [HDL], Low-density Lipoprotein Cholesterol [LDL], Triglycerides, LDL Subfractions)
Hide Description [Not Specified]
Time Frame 60 weeks from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.
Arm/Group Title Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
Hide Arm/Group Description:
Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Occurrences of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia, and Serious Hypoglycemia
Hide Description
  • Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat & a cold, clammy feeling.
  • Mild–to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL
  • Severe hypoglycemia: assistance of another party is required & either:

    • SMBG of <36 mg/dL, or
    • with prompt response to treatment with oral carbohydrates, IV glucose or glucagon.
  • Serious hypoglycemia:

    • Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion.
Time Frame 60 weeks from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
Hide Arm/Group Description:
Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Overall Number of Participants Analyzed 128 128 130
Measure Type: Number
Unit of Measure: Participants
Any reported symptomatic Hypoglycemic event 110 107 112
Symptomatic events with Self-monitored BG (SMBG) 109 106 112
SMBG <70 mg/dL with symptom 107 102 112
SMBG <50mg/dL with symptom 74 71 85
SMBG <36 mg/dL with symptom 23 24 35
Severe Hypoglycemias 8 10 5
Severe only due to SMBG <36mg/dL 1 1 0
Severe: Prompt response to CHO countermeasure 4 5 4
Severe:SMBG<36mg/dL, prompt response to CHO 3 4 2
Serious hypoglycemia 3 1 0
Coma/Loss of Consciousness 3 1 0
7.Secondary Outcome
Title Rate of Hypoglycemia, Symptomatic Hypoglycemia, Severe Hypoglycemia and Serious Hypoglycemia
Hide Description
  • Symptomatic hypoglycemia (BG<70 mg/dL, BG<50 mg/dL): including 1 or more symptoms: headache, dizziness, general feeling of weakness, drowsiness, confusion, pallor, irritability, trembling, sweating, rapid heartbeat & a cold, clammy feeling.
  • Mild–to-moderate hypoglycemia: SMBG ≥ 36 mg/dL but <70 mg/dL
  • Severe hypoglycemia: assistance of another party is required & either:

    • SMBG of <36 mg/dL, or
    • with prompt response to treatment with oral carbohydrates, IV glucose or glucagon.
  • Serious hypoglycemia:

    • Hypoglycemia with coma/loss of consciousness Or Hypoglycemia seizure/convulsion.
Time Frame 60 Weeks from Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
Hide Arm/Group Description:
Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
Overall Number of Participants Analyzed 128 128 130
Mean (Standard Deviation)
Unit of Measure: events/ patient-year
Exposure (Patient-years) 0.941  (0.3285) 0.943  (0.3692) 0.967  (0.3118)
Hypoglycemic (HE) event with SMBG <70mg/dL 30.1  (35.54) 16.5  (20.35) 25.3  (26.81)
HE with SMBG <50mg/dL 4.9  (7.48) 3.3  (5.74) 5.6  (8.17)
HE with SMBG <36mg/dL 0.3  (0.87) 0.3  (0.76) 0.6  (1.55)
Severe HE (BG<36mg/dL or prompt response to CHO 0.1  (0.31) 0.1  (0.53) 0.1  (0.30)
Serious HE (coma/loss of consciousness,seizure) 0.0  (0.14) 0.0  (0.09) 0.0  (0.00)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
Hide Arm/Group Description Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%) Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
All-Cause Mortality
Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/128 (17.19%)   20/128 (15.63%)   13/130 (10.00%) 
Blood and lymphatic system disorders       
Anaemia   1/128 (0.78%)  0/128 (0.00%)  1/130 (0.77%) 
Cardiac disorders       
Acute myocardial infarction   0/128 (0.00%)  0/128 (0.00%)  2/130 (1.54%) 
Angina pectoris   0/128 (0.00%)  1/128 (0.78%)  0/130 (0.00%) 
Angina unstable   0/128 (0.00%)  1/128 (0.78%)  0/130 (0.00%) 
Aortic valve stenosis   0/128 (0.00%)  0/128 (0.00%)  1/130 (0.77%) 
Cardiac failure congestive   1/128 (0.78%)  0/128 (0.00%)  0/130 (0.00%) 
Cardio-respiratory arrest   1/128 (0.78%)  0/128 (0.00%)  0/130 (0.00%) 
Coronary artery disease   3/128 (2.34%)  2/128 (1.56%)  1/130 (0.77%) 
Coronary artery occlusion   0/128 (0.00%)  0/128 (0.00%)  1/130 (0.77%) 
Myocardial infarction   0/128 (0.00%)  1/128 (0.78%)  1/130 (0.77%) 
Gastrointestinal disorders       
Gastrooesophageal reflux disease   1/128 (0.78%)  0/128 (0.00%)  0/130 (0.00%) 
Pancreatitis   0/128 (0.00%)  0/128 (0.00%)  1/130 (0.77%) 
General disorders       
Chest Discomfort   0/128 (0.00%)  0/128 (0.00%)  1/130 (0.77%) 
Non-cardiac chest pain   0/128 (0.00%)  1/128 (0.78%)  0/130 (0.00%) 
Immune system disorders       
Drug hypersensitivity   0/128 (0.00%)  0/128 (0.00%)  1/130 (0.77%) 
Infections and infestations       
Appendicitis   0/128 (0.00%)  1/128 (0.78%)  0/130 (0.00%) 
Bronchitis   2/128 (1.56%)  0/128 (0.00%)  0/130 (0.00%) 
Bronchopneumonia   1/128 (0.78%)  0/128 (0.00%)  0/130 (0.00%) 
Cellulitis   1/128 (0.78%)  1/128 (0.78%)  0/130 (0.00%) 
Gastroenteritis   1/128 (0.78%)  1/128 (0.78%)  0/130 (0.00%) 
Pneumonia   1/128 (0.78%)  0/128 (0.00%)  0/130 (0.00%) 
Scrotal abscess   1/128 (0.78%)  0/128 (0.00%)  0/130 (0.00%) 
Injury, poisoning and procedural complications       
Burns second degree   1/128 (0.78%)  0/128 (0.00%)  0/130 (0.00%) 
Injury   0/128 (0.00%)  1/128 (0.78%)  0/130 (0.00%) 
Overdose   2/128 (1.56%)  5/128 (3.91%)  0/130 (0.00%) 
Metabolism and nutrition disorders       
Hypoglycaemia   1/128 (0.78%)  2/128 (1.56%)  0/130 (0.00%) 
Hypoglycaemic unconsciousness   1/128 (0.78%)  1/128 (0.78%)  0/130 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain   0/128 (0.00%)  0/128 (0.00%)  1/130 (0.77%) 
Intervertebral disc protrusion   0/128 (0.00%)  1/128 (0.78%)  0/130 (0.00%) 
Musculoskeletal pain   1/128 (0.78%)  0/128 (0.00%)  0/130 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder cancer recurrent   0/128 (0.00%)  1/128 (0.78%)  0/130 (0.00%) 
Bladder transitional cell carcinoma   0/128 (0.00%)  1/128 (0.78%)  0/130 (0.00%) 
Bone cancer metastatic   1/128 (0.78%)  0/128 (0.00%)  0/130 (0.00%) 
Breast cancer   1/128 (0.78%)  0/128 (0.00%)  0/130 (0.00%) 
Prostate cancer   1/128 (0.78%)  0/128 (0.00%)  0/130 (0.00%) 
Squamous cell carcinoma   0/128 (0.00%)  0/128 (0.00%)  1/130 (0.77%) 
Nervous system disorders       
Convulsion   1/128 (0.78%)  0/128 (0.00%)  0/130 (0.00%) 
Hypoglycaemic coma   2/128 (1.56%)  0/128 (0.00%)  0/130 (0.00%) 
Myelitis transverse   0/128 (0.00%)  1/128 (0.78%)  0/130 (0.00%) 
Transient ischaemic attack   1/128 (0.78%)  0/128 (0.00%)  0/130 (0.00%) 
Renal and urinary disorders       
Nephrolithiasis   1/128 (0.78%)  1/128 (0.78%)  0/130 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease   1/128 (0.78%)  0/128 (0.00%)  0/130 (0.00%) 
Dyspnoea exertional   1/128 (0.78%)  0/128 (0.00%)  0/130 (0.00%) 
Pulmonary embolism   0/128 (0.00%)  1/128 (0.78%)  0/130 (0.00%) 
Pulmonary oedema   1/128 (0.78%)  0/128 (0.00%)  0/130 (0.00%) 
Vascular disorders       
Aortic stenosis   0/128 (0.00%)  0/128 (0.00%)  1/130 (0.77%) 
Arterial stenosis   0/128 (0.00%)  1/128 (0.78%)  0/130 (0.00%) 
Arteriosclerosis   0/128 (0.00%)  0/128 (0.00%)  1/130 (0.77%) 
Deep vein thrombosis   0/128 (0.00%)  1/128 (0.78%)  0/130 (0.00%) 
Hypertensive crisis   0/128 (0.00%)  1/128 (0.78%)  0/130 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD) Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   99/128 (77.34%)   84/128 (65.63%)   84/130 (64.62%) 
General disorders       
Edema Peripheral   16/128 (12.50%)  6/128 (4.69%)  11/130 (8.46%) 
Infections and infestations       
Nasopharyngitis   11/128 (8.59%)  12/128 (9.38%)  14/130 (10.77%) 
Upper respiratory tract infection   9/128 (7.03%)  17/128 (13.28%)  9/130 (6.92%) 
Bronchitis   11/128 (8.59%)  7/128 (5.47%)  6/130 (4.62%) 
Influenza   6/128 (4.69%)  7/128 (5.47%)  7/130 (5.38%) 
Sinusitis   7/128 (5.47%)  7/128 (5.47%)  6/130 (4.62%) 
Investigations       
Weight increased   8/128 (6.25%)  3/128 (2.34%)  1/130 (0.77%) 
Metabolism and nutrition disorders       
Hypoglycemia   6/128 (4.69%)  7/128 (5.47%)  5/130 (3.85%) 
Musculoskeletal and connective tissue disorders       
Arthralgia   9/128 (7.03%)  6/128 (4.69%)  7/130 (5.38%) 
Pain in extremity   10/128 (7.81%)  4/128 (3.13%)  4/130 (3.08%) 
Back pain   4/128 (3.13%)  6/128 (4.69%)  7/130 (5.38%) 
Vascular disorders       
Hypertension   4/128 (3.13%)  2/128 (1.56%)  7/130 (5.38%) 
Indicates events were collected by systematic assessment
The study was terminated prematurely due to technical issues with electronic diary data. Consequently, some of the initially planned efficacy analyses, based directly or indirectly on the e-diary data, were not performed.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
Results Point of Contact
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Name/Title: Medical Affairs study director
Organization: sanofi-aventis
EMail: publicregistryUSMA@sanofi-aventis.com
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Responsible Party: Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00283049     History of Changes
Other Study ID Numbers: HOE901_4052
First Submitted: January 26, 2006
First Posted: January 27, 2006
Results First Submitted: December 16, 2009
Results First Posted: February 19, 2010
Last Update Posted: January 13, 2011