Study: NCT00081328

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Endocrine disorders
Frequency: 5 affected / 232 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 232 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 232 at risk

Adverse event: Lactic acidosis
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 232 at risk

Adverse event: all other
Serious: yes
Organ System: General disorders
Frequency: 32 affected / 232 at risk

Adverse event: Skin rash on physical examination
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 108 affected / 232 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Frequent stomach pains, bloating, nausea, diarrhea, or loss of appetite.
Frequency: 129 affected / 232 at risk

Adverse event: Edema on physical examination
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 232 at risk

Adverse event: Hyperglycemia symptoms
Serious: no
Organ System: Endocrine disorders
Notes: Symptoms of diabetes out of control included nocturia more than once a night on a regular basis, enuresis, increased thirst, urinating more often than usual.
Frequency: 115 affected / 232 at risk

Adverse event: Infection requiring medical attention
Serious: no
Organ System: Infections and infestations
Frequency: 149 affected / 232 at risk

Adverse event: Sprain or fracture requiring medical attention
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 66 affected / 232 at risk

Adverse event: Muscle ache or pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 68 affected / 232 at risk

Adverse event: Mild hypoglycemia
Serious: no
Organ System: Endocrine disorders
Frequency: 10 affected / 232 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 233 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 5 affected / 233 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 233 at risk

Adverse event: all other
Serious: yes
Organ System: General disorders
Frequency: 25 affected / 233 at risk

Adverse event: Skin rash on physical examination
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 101 affected / 233 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Frequent stomach pains, bloating, nausea, diarrhea, or loss of appetite.
Frequency: 100 affected / 233 at risk

Adverse event: Edema on physical examination
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 233 at risk

Adverse event: Hyperglycemia symptoms
Serious: no
Organ System: Endocrine disorders
Notes: Symptoms of diabetes out of control included nocturia more than once a night on a regular basis, enuresis, increased thirst, urinating more often than usual.
Frequency: 98 affected / 233 at risk

Adverse event: Infection requiring medical attention
Serious: no
Organ System: Infections and infestations
Frequency: 120 affected / 233 at risk

Adverse event: Sprain or fracture requiring medical attention
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 53 affected / 233 at risk

Adverse event: Muscle ache or pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 53 affected / 233 at risk

Adverse event: Mild hypoglycemia
Serious: no
Organ System: Endocrine disorders
Frequency: 19 affected / 233 at risk

Adverse event: Diabetic ketoacidosis
Serious: yes
Organ System: Endocrine disorders
Frequency: 3 affected / 234 at risk

Adverse event: Hyperglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 234 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 2 affected / 234 at risk

Adverse event: all other
Serious: yes
Organ System: General disorders
Frequency: 51 affected / 234 at risk

Adverse event: Skin rash on physical examination
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 95 affected / 234 at risk

Adverse event: Gastrointestinal symptoms
Serious: no
Organ System: Gastrointestinal disorders
Notes: Frequent stomach pains, bloating, nausea, diarrhea, or loss of appetite.
Frequency: 136 affected / 234 at risk

Adverse event: Edema on physical examination
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 17 affected / 234 at risk

Adverse event: Hyperglycemia symptoms
Serious: no
Organ System: Endocrine disorders
Notes: Symptoms of diabetes out of control included nocturia more than once a night on a regular basis, enuresis, increased thirst, urinating more often than usual.
Frequency: 103 affected / 234 at risk

Adverse event: Infection requiring medical attention
Serious: no
Organ System: Infections and infestations
Frequency: 151 affected / 234 at risk

Adverse event: Sprain or fracture requiring medical attention
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 64 affected / 234 at risk

Adverse event: Muscle ache or pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 77 affected / 234 at risk

Adverse event: Mild hypoglycemia
Serious: no
Organ System: Endocrine disorders
Frequency: 8 affected / 234 at risk