Evaluation of Insulin Glargine Versus Sitagliptin in Insulin-naive Patients

What Was Tested

The trial (phase 4) is built around Insulin Glargine.

It had two arms (groups): Insulin Glargine (experimental) and Sitagliptin (active comparator).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 515 actual participants took part.

It was open to people of any sex aged from 35 years up to 70 years.

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

Examples of who could join: With type 2 diabetes diagnosed for at least 6 months,. Not previously treated with insulin,. Body Mass Index (BMI) between 25 and 45 kg/m² inclusively,. Signed informed consent obtained prior any study procedures,. Willingness and ability to comply with the study protocol.

The full record lists 8 inclusion and 18 exclusion criteria; among the exclusions: treatment with oral antidiabetic drugs other than metformin within the last 3 months,; previous treatment with the combination of metformin + sulfonylurea for more than 1 year,; previous treatment with glucagon like peptide-1 (glp-1) agonists or dipeptidyl peptidase (dpp) iv inhibitors,.

How the Study Was Run

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

The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.

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 2008-11 with completion listed for 2011-07.

It ran at 17 sites in United States (1), Austria (1), Brazil (1), Colombia (1), Egypt (1) and Greece (1).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: HbA1c: Change From Baseline to Study Endpoint (time frame: baseline (week 0), study endpoint: visit 14 (week 24) or visit 11 (week 12) if value not available at visit 14).

It also tracked 9 secondary outcomes, for example Self-monitored Fasting Plasma Glucose (SMFPG) Mean : Change From Baseline to Study Endpoint, 7-point Plasma Glucose Profile: Change From Baseline to Study Endpoint, Lipid Profile: Change From Baseline to Study Endpoint, Change in Body Weight From Baseline to Study Endpoint, Number of Patients With at Least One Episode of Symptomatic Hypoglycemia and Number of Patients With at Least One Episode of Severe Symptomatic Hypoglycemia.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin Glargine in 515 people.

With 515 participants it is a large trial for this field.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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