Taspoglutide NCT00909597

Trial name or title	A multicenter, randomised, double blind (double dummy), active controlled study to compare the safety, tolerability and effect on glycaemic control of taspoglutide versus pioglitazone in type 2 diabetes patients inadequately controlled on therapy with sulphonylurea or metformin plus sulphonylurea
Methods	TRIAL DESIGN: Randomised, double blind (participant, investigator), three arm, phase III trial, parallel assignment, multi centre, multinational, safety and efficacy study DURATION OF INTERVENTION: 104 weeks (24 months) COUNTRY: USA, Europe, North and South America
Participants	INCLUSION CRITERIA: Patients (18 years to 75 years of age and both sexes) with type 2 diabetes treated with stable dose of sulphonylurea monotherapy or metformin plus sulphonylurea for ≥ 12 weeks prior to screening. HbA1c ≥ 7.0% and ≤ 10.0% at screening stable weight ± 5% for ≥ 12 weeks prior to screening
Interventions	Taspoglutide: 10 mg subcutaneous injection once weekly Taspoglutide: 10 mg subcutaneous injection once weekly for 4 weeks followed by 20 mg subcutaneous once weekly Pioglitazone: 30 mg orally once daily for 4 weeks followed by 45 mg once daily
Outcomes	PRIMARY OUTCOME: Absolute change in HbA1c from baseline at 24 weeks SECONDARY OUTCOMES: Proportion of participants achieving target HbA1c ≤ 6.5%, ≤ 7.0% at weeks 24, 52 and 104; absolute/percentage change from baseline in body weight, responder rates for body weight, absolute/percentage change from baseline in waist and hip circumference, absolute/percentage change from baseline in fasting plasma glucose at weeks 24, 52 and 104; adverse events, laboratory parameters, cardiovascular events at each clinic visit up to 106 weeks
Starting date	May 2009, completed (last updated on June 15, 2011)
Contact information	Hoffmann‐La Roche
Notes	Study ID numbers: BC21893, 2009‐009157‐24, ClinicalTrials.gov Identifier: NCT00909597

^{BG: biguanide; BMI: body mass index; , CV: cardiovascular; DPP‐4: dipeptidyl peptidase‐4 inhibitor; ECG: electrocardiography; FPG: fasting plasma glucose; HbA1c: glycosylated haemoglobin A1c; HOMA‐B: homeostatic model assessment‐beta cell function; HOMA‐IS: homeostatic model assessment‐insulin sensitivity; HOMA‐IR: homeostatic model assessment‐insulin resistance; Met: metformin; OAD: oral antidiabetic drug; PG: plasma glucose; PPG: post‐prandial glucose; QD: once daily; SMPG: self‐measured plasma glucose; SU: sulphonylurea; TZD: thiazolidinedione; WHO: World Health Organization.}