A Phase 3 interventional study of insulin glargine and metformin in Diabetes Mellitus Type 2, sponsored by Hoffmann-La Roche. Terminated at 56 sites in 7 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 3, Interventional, and Treatment
This randomized, open-label, parallel arm study will compare the safety, tolerability and effect on glycemic control of taspoglutide versus insulin glargine in insulin-naïve patients with type 2 diabetes mellitus inadequately controlled on merformin and sulfonylurea combination therapy. Patients will be randomized to receive either taspoglutide 10mg subcutaneously (sc) weekly, or taspoglutide 10mg sc weekly for 4 weeks followed by 20mg sc weekly, or insulin glargine at an initial dose of 10 international units sc daily. Metformin treatment will be continued in all patients throughout the study, whereas sulfonylurea will be discontinued before starting study treatment. Anticipated time on study treatment is 24 weeks, with an option to continue the assigned treatment for another 28 weeks. Target sample size is 500-600 patients.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 370 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: metformin · Drug: taspoglutide
Drug: metformin · Drug: taspoglutide
Drug: insulin glargine · Drug: metformin
initial dose 10 international units (IU) sc daily, titrated according to the mean FPG, 24 (-52) weeks
as prescribed
10mg sc weekly, 24 (-52) weeks
10mg sc weekly the 1st 4 weeks followed by 20mg sc weekly, 24 (-52) weeks
Glycemic control assessed by HbA1c
Time frame: week 24
Fasting plasma glucose, incidence of hypoglycemia, proportion of patients achieving target HbA1c
Time frame: week 24
Body weight, lipid profile (triglycerides, total cholesterol, LDL and HDL cholesterol, LDL/HDL ratio)
Time frame: week 24
Safety and tolerability: Adverse events (including hypoglycemia), vital signs, laboratory parameters
Time frame: throughout study, laboratory assessments weeks 12, 24, 32 and 52
Meal tolerance test (in a subset of patients): Glucose, insulin, C-peptide, glucagon values
Time frame: week 24
This study is terminated, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche