Related trials
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COSMIC, 2009 - vs
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See also:
All test diabète clinical trials
All diabetes clinical trials
All type 2 diabetes - sanofi clinical trials
All clinical trials of insulin secretagogues peptides (incretins)
All clinical trials of liraglutide
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Treatments
Studied treatment |
Liraglutide 1.2–1.8 mg daily
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Control treatment |
Placebo on-top of sulphonylureas
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Concomittant treatment |
sulphonylureas
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Patients
Inclusion criteria |
1) Type 2 diabetes; 2) Treatment with oral anti-diabetic drugs for at least 3 months; 3) HbA1c: 7.0-11.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy; 4) Body Mass Index (BMI) less than or equal to 45.0 kg/m2.;
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Exclusion criteria |
1) Treatment with insulin within the last three months; 2) Treatment with any drug that could interfere with the glucose level; 3) Any serious medical condition; 4) Females who are pregnant, have the intention of becoming pregnant or are breastfeeding;
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Baseline characteristics |
Age (year) |
56 |
Duration of diabetes (year) |
7.9 y |
HbA1c (%) |
8.4 |
BMI |
30.0 |
Add-on to |
SU |
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Method and design
Randomized effectives |
695 / 115 (studied vs. control) |
Blinding |
not reported |
Follow-up duration |
26 weeks |
Remarks |
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Remarks / Comments
Results
Endpoint
Studied treat. n/N
Control treat. n/N
Graph
RR [95% CI]
nausea
52 / 695
2 / 115
classic
4,30 [1,06;17,42]
severe hypoglycemia
1 / 695
0 / 115
classic
0,83 [0,01;60,34]
0
2
1.0
Relative risks
|
Endpoint |
Events (%) |
Relative Risk |
95% CI |
Endpoint definition in the trial |
Ref |
Studied treat. |
Control treat. |
severe hypoglycemia
|
1 / 695 (0,1%) |
0 / 115 (0,4%) |
0,33 |
[0,01;9,81] |
|
12053 |
nausea
|
52 / 695 (7,5%) |
2 / 115 (1,7%) |
4,30 |
[1,06;17,42] |
|
0 |
The primary endpoint (if exists) appears in blod characters
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Reference(s) used for data extraction:
0:
12053: Monami M, Marchionni N, Mannucci EGlucagon-like peptide-1 receptor agonists in type 2 diabetes: a meta-analysis of randomized clinical trials.Eur J Endocrinol 2009;160:909-17
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Endpoint |
studied treat. |
control treat. |
mean diff |
Absolute risk reduction
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Endpoint |
Events rate |
Absolute risk reduction (ARR) |
Studied treat. |
Control treat. |
nausea |
7,48% |
1,74% |
5,7%
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Meta-analysis of all similar trials:
antidiabetic drugs in test diabète for type 2 daibetes (NIDD)
insulin secretagogues peptides (incretins) in diabetes for all type of patients
insulin secretagogues peptides (incretins) in type 2 diabetes - sanofi for all type of patients
Reference(s)
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