A Study to Compare Taspoglutide and Insulin Glargine in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin and Sulfonylurea Combination Therapy

What Was Tested

This registered phase 3 trial tested Insulin Glargine.

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.

Metformin treatment will be continued in all patients throughout the study, whereas sulfonylurea will be discontinued before starting study treatment.

It had three arms (groups): 1 (experimental), 2 (experimental) and 3 (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 370 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Adult patients, 18-75 years of age. Fasting C-peptide \>/=1ng/ml. Treatment-naïve for insulin.

The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: diagnosis or history of type 1 diabetes mellitus or secondary forms of diabetes; clinically symptomatic gastrointestinal disease; history of chronic pancreatitis or acute idiopathic pancreatitis.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.

The Insulin Glargine group and the comparison group ran side by side rather than switching.

Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.

It started in 2010-01 with completion listed for 2010-12.

It ran at 56 sites in China (16), South Korea (16), Malaysia (7), Philippines (6), Taiwan (6) and Thailand (4).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Glycemic control assessed by HbA1c (time frame: week 24).

It also tracked 4 secondary outcomes, for example Fasting plasma glucose, incidence of hypoglycemia, proportion of patients achieving target HbA1c, Body weight, lipid profile (triglycerides, total cholesterol, LDL and HDL cholesterol, LDL/HDL ratio), Safety and tolerability: Adverse events (including hypoglycemia), vital signs, laboratory parameters and Meal tolerance test (in a subset of patients): Glucose, insulin, C-peptide, glucagon values.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Insulin Glargine in 370 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Glargine compound page, all human trials.