Continuous glucose profiles with vildagliptin versus sitagliptin in add-on to metformin: results from the randomized Optima study.
Diabetes Metab
; 38(4): 359-66, 2012 Oct.
Article
in En
| MEDLINE
| ID: mdl-22809630
ABSTRACT
AIM:
To compare continuous glucose monitoring (CGM) profiles on vildagliptin versus sitagliptin in addition to metformin, in patients with inadequately controlled type 2 diabetes mellitus (HbA(1c) 6.5-8.0%).METHODS:
A multicenter, prospective, randomised, open-label study with blinded endpoint analysis. CGM data acquired over three days--firstly on metformin alone and then 8 weeks after the addition of either vildagliptin (n=14) or sitagliptin (n=16)--were blinded and analyzed centrally.RESULTS:
In comparable populations with a mean baseline HbA1c of 7.1%, 24-hour glucose variability--measured by mean amplitude of glucose excursions and standard deviation of mean glucose concentration--showed similar improvement on both drugs versus metformin alone. In contrast, a series of predefined parameters reflecting daily glycaemic control--mean 24-hour blood glucose concentration, and the times spent in the optimal glycaemic range (70-140 mg/dL) and above the hyperglycaemic thresholds of 140 and 180 mg/dL together with the corresponding AUC values--were significantly improved from baseline only in the vildagliptin arm. In addition, overall hyperglycaemia (AUC[24 h] > 100 mg/dL) significantly dropped from baseline on vildagliptin [-37%] but not on sitagliptin [-9%], while postprandial hyperglycaemia (AUC[0-4 h] × 3) was significantly reduced on both, and basal hyperglycaemia (overall--postprandial hyperglycaemia was reduced only on vildagliptin [-41%; P = 0.04]).CONCLUSIONS:
The addition of a DPP-4 inhibitor significantly reduced glycaemic variability with no difference between the two drugs. However, vildagliptin induced better circadian glycaemic control than sitagliptin with a significant decrease on overall hyperglycemia, mainly driven by reduction on basal hyperglycaemia.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Pyrazines
/
Pyrrolidines
/
Triazoles
/
Blood Glucose
/
Adamantane
/
Diabetes Mellitus, Type 2
/
Dipeptidyl-Peptidase IV Inhibitors
/
Hyperglycemia
/
Hypoglycemic Agents
/
Metformin
Type of study:
Clinical_trials
/
Observational_studies
/
Risk_factors_studies
Limits:
Aged80
Country/Region as subject:
Europa
Language:
En
Journal:
Diabetes Metab
Journal subject:
ENDOCRINOLOGIA
/
METABOLISMO
Year:
2012
Document type:
Article
Affiliation country:
France