| Methods |
DURATION OF INTERVENTION:
24 weeks
DURATION OF FOLLOW‐UP:
24 weeks
RUN‐IN PERIOD:
two week wash‐out period (with cessation of previous antidiabetic medication)
LANGUAGE OF PUBLICATION:
English |
| Participants |
WHO PARTCIPATED:
mainly white patients with type 2 diabetes mellitus
INCLUSION CRITERIA:
participants >=18 years, BMI <45 kg/m2, had type 2 diabetes for at least 12 months, with HbA1c >7% and <12%; previously treated with sulphonylurea or metformin (at 50% or more of max recommended dose) for at least 3 months
EXCLUSION CRITERIA:
patients treated within the previous 3 months with: insulin, repaglinide, TZDs, alpha‐glucosidase inhibitors, combination therapy with antidiabetic medications.
treatment discontinued for unacceptable hyperglycaemia (FPG above 270 mg/dl on 2 or more consecutive occasions in spite of dose escalations to the maximum allowed dosages), in absence of treatable intercurrent illness
DIAGNOSTIC CRITERIA:
not stated
CO‐MORBIDITIES:
not stated
CO‐MEDICATIONS:
not stated |
| Interventions |
NUMBER OF STUDY CENTRES:
multi, not stated
COUNTRY/ LOCATION:
USA
SETTING:
unclear
INTERVENTION 1 (DOSE/DAY):
pioglitazone; 30 mg/day
CONTROL 1 (DOSE/DAY):
repaglinide; dosage adjusted up to max of 4 mg/meal (target FPG values of 80‐120 mg/dl), median final dose 6.0 mg/day
CONTROL 2 (DOSE/DAY):
repaglinide+pioglitazone; pioglitazone 30 mg/day, repaglinide adjusted as above, median final dose 10.0 mg/day
TREATMENT BEFORE STUDY:
sulphonylurea or metformin
TITRATION:
‐ for repaglinide: 12 weeks of dose optimisation ‐ repaglinide monotherapy initiated at 0.5 mg/meal if HbA1c was at 8% or below, or at 1mg per meal for all other patients;
‐ in repaglinide/pioglitazone combination therapy, repaglinide as above, plus 30 mg q.d. pioglitazone; patients receiving repaglinide had dosage adjusted to achieve FPG values of 80‐120 mg/dl. |
| Outcomes |
PRIMARY OUTCOMES:
changes in HbA1c values from baseline to the end of study treatment
SECONDARY OUTCOMES:
FPG, lipids, adverse events, hypoglycaemia |
| Notes |
AIM OF STUDY:
to assess the efficacy, safety and tolerability of the repaglinide+pioglitazone combination therapy in comparison to monotherapy with either agent after unsatisfactory response to sulphonylurea or metformin monotherapy |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
