Trial Outcomes & Findings for Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients (NCT NCT01147627)
NCT ID: NCT01147627
Last Updated: 2013-08-21
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
416 participants
Primary outcome timeframe
48 weeks
Results posted on
2013-08-21
Participant Flow
Participant milestones
| Measure |
Exenatide
5 µg was injected twice-daily subcutaneously increasing to 10 µg twice-daily after 4 weeks. Those who experienced hypoglycaemia frequently or could not tolerate adverse events were instructed to reduce the dose to 5 µg twice-daily.
|
Premixed Insulin Analog
Premixed insulin was injected twice-daily commencing with 0.4 IU/kg daily, with 50% given 15 minutes before breakfast and dinner respectively
|
Pioglitazone
Pioglitazone was commenced at a dose of 30 mg daily, increasing to 45 mg daily after 4 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
142
|
138
|
136
|
|
Overall Study
COMPLETED
|
110
|
114
|
118
|
|
Overall Study
NOT COMPLETED
|
32
|
24
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Different Interventions on Glycemic Control and β-cell Function in Newly Diagnosed Type 2 Diabetic Patients
Baseline characteristics by cohort
| Measure |
Exenatide
n=142 Participants
|
Premixed Insulin Analog
n=138 Participants
|
Thiazolidinedione
n=136 Participants
|
Total
n=416 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
132 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
389 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Age Continuous
|
49.89 years
STANDARD_DEVIATION 9.64 • n=5 Participants
|
51.39 years
STANDARD_DEVIATION 9.65 • n=7 Participants
|
49.66 years
STANDARD_DEVIATION 8.86 • n=5 Participants
|
50.31 years
STANDARD_DEVIATION 9.40 • n=4 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
150 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
85 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
266 Participants
n=4 Participants
|
|
Region of Enrollment
China
|
142 participants
n=5 Participants
|
138 participants
n=7 Participants
|
136 participants
n=5 Participants
|
416 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 48 weeksOutcome measures
| Measure |
Exenatide
n=110 Participants
|
Premixed Insulin Analog
n=114 Participants
|
Thiazolidinedione
n=118 Participants
|
|---|---|---|---|
|
the Comparison Between Treatment Groups of the Changes From Baseline in HbA1c at 48 Weeks
|
-1.8 percentage of HbA1c
Standard Deviation 1.29
|
-1.74 percentage of HbA1c
Standard Deviation 1.16
|
-1.47 percentage of HbA1c
Standard Deviation 1.30
|
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 48 weeksOutcome measures
Outcome data not reported
Adverse Events
Exenatide
Serious events: 5 serious events
Other events: 69 other events
Deaths: 0 deaths
Premixed Insulin Analog
Serious events: 1 serious events
Other events: 42 other events
Deaths: 0 deaths
Thiazolidinedione
Serious events: 7 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Exenatide
n=142 participants at risk
|
Premixed Insulin Analog
n=138 participants at risk
|
Thiazolidinedione
n=136 participants at risk
|
|---|---|---|---|
|
Vascular disorders
Cerebral infarction
|
0.00%
0/142
|
0.00%
0/138
|
0.74%
1/136
|
|
Musculoskeletal and connective tissue disorders
Cervical spondylosis
|
0.00%
0/142
|
0.00%
0/138
|
0.74%
1/136
|
|
Musculoskeletal and connective tissue disorders
Thigh myofascitis
|
0.70%
1/142
|
0.00%
0/138
|
0.00%
0/136
|
|
Gastrointestinal disorders
Acute pancreatitis
|
0.70%
1/142
|
0.00%
0/138
|
0.00%
0/136
|
|
Skin and subcutaneous tissue disorders
Furuncle and secondary skin infection
|
0.00%
0/142
|
0.00%
0/138
|
0.74%
1/136
|
|
Renal and urinary disorders
Acute nephritis
|
0.00%
0/142
|
0.00%
0/138
|
0.74%
1/136
|
|
Nervous system disorders
Facial neuritis
|
0.00%
0/142
|
0.00%
0/138
|
0.74%
1/136
|
|
Musculoskeletal and connective tissue disorders
Linguinal herniation
|
0.00%
0/142
|
0.00%
0/138
|
0.74%
1/136
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/142
|
0.00%
0/138
|
0.74%
1/136
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocellular carcinoma
|
0.70%
1/142
|
0.00%
0/138
|
0.00%
0/136
|
|
Renal and urinary disorders
Proteinuria
|
0.70%
1/142
|
0.00%
0/138
|
0.00%
0/136
|
Other adverse events
| Measure |
Exenatide
n=142 participants at risk
|
Premixed Insulin Analog
n=138 participants at risk
|
Thiazolidinedione
n=136 participants at risk
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
26.1%
37/142
|
0.72%
1/138
|
0.74%
1/136
|
|
Gastrointestinal disorders
Vomitting
|
10.6%
15/142
|
0.72%
1/138
|
0.74%
1/136
|
|
Gastrointestinal disorders
abdominal pain
|
3.5%
5/142
|
1.4%
2/138
|
3.7%
5/136
|
|
Gastrointestinal disorders
diarrhea
|
4.2%
6/142
|
0.72%
1/138
|
2.9%
4/136
|
|
Gastrointestinal disorders
abdominal distention
|
5.6%
8/142
|
0.00%
0/138
|
0.74%
1/136
|
|
Gastrointestinal disorders
appetite loss
|
5.6%
8/142
|
0.00%
0/138
|
0.00%
0/136
|
|
Gastrointestinal disorders
constipation
|
4.2%
6/142
|
0.00%
0/138
|
0.74%
1/136
|
|
Nervous system disorders
dizziness
|
12.7%
18/142
|
5.1%
7/138
|
2.9%
4/136
|
|
General disorders
edema
|
0.00%
0/142
|
0.00%
0/138
|
8.8%
12/136
|
|
Nervous system disorders
numbness
|
2.8%
4/142
|
1.4%
2/138
|
3.7%
5/136
|
|
General disorders
fatigue
|
2.1%
3/142
|
2.2%
3/138
|
2.9%
4/136
|
|
Skin and subcutaneous tissue disorders
injection site reaction
|
2.8%
4/142
|
4.3%
6/138
|
0.00%
0/136
|
|
Cardiac disorders
palpitation
|
2.8%
4/142
|
1.4%
2/138
|
1.5%
2/136
|
|
Nervous system disorders
headache
|
2.1%
3/142
|
1.4%
2/138
|
1.5%
2/136
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory tract infection
|
11.3%
16/142
|
9.4%
13/138
|
8.1%
11/136
|
|
Eye disorders
blurred vision
|
1.4%
2/142
|
0.72%
1/138
|
2.2%
3/136
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.00%
0/142
|
0.72%
1/138
|
2.9%
4/136
|
|
Cardiac disorders
chest tightness
|
1.4%
2/142
|
0.00%
0/138
|
2.2%
3/136
|
|
Skin and subcutaneous tissue disorders
rash
|
0.70%
1/142
|
1.4%
2/138
|
1.5%
2/136
|
|
Musculoskeletal and connective tissue disorders
skelalgia
|
2.1%
3/142
|
0.72%
1/138
|
0.74%
1/136
|
|
Nervous system disorders
toothache
|
2.1%
3/142
|
1.4%
2/138
|
0.00%
0/136
|
|
Immune system disorders
allergy
|
0.00%
0/142
|
0.72%
1/138
|
0.00%
0/136
|
|
General disorders
Weight gain
|
0.00%
0/142
|
0.72%
1/138
|
0.00%
0/136
|
Additional Information
Dr. Jianping Weng
The Third Affiliated Hospital of Sun Yat-sen University
Phone: 86-20-85253162
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place