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Insulin Glargine Combination Therapies in Type II Diabetics
Plain-language guide to NCT00783744: phase 3 randomized trial of Insulin Glargine and NPH Insulin (isophane), 375 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00783744
- Phase
- phase 3
- Status
- completed
- Start
- 2001-12
- Completion (planned or actual)
- 2003-08
- Participants
- 375 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Insulin Glargine and NPH Insulin (isophane).
It had two arms (groups): 1 (experimental) and 2 (active comparator).
Insulin Glargine + Glimepiride + Metformin.
Insulin monotherapy with premixed insulin NPH 30/70.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 375 actual participants took part.
It was open to people of any sex aged from 35 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: BMI ≤ 35 kg/m².
The full record lists 4 inclusion and 0 exclusion criteria.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Insulin Glargine study did not mask who received what.
It started in 2001-12 with completion listed for 2003-08.
It ran at 10 sites in Austria (1), Finland (1), France (1), Germany (1), Italy (1) and Netherlands (1).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 6 secondary outcomes, for example Change of fasting blood glucose, Change of nocturnal & mean daytime blood glucose, Change of fasting plasma glucose, Frequency of subjects with hypoglycemic events (overall, severe, non-severe, nocturnal, asymptomatic, symptomatic) and Frequency of hypoglycemic events(overall, severe, non-severe, nocturnal, asymptomatic, symptomatic).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine and NPH Insulin (isophane) in 375 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin Glargine compound page and the NPH Insulin (isophane) compound page, all human trials.
Our Notes on the Compounds
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
NPH Insulin (isophane): An intermediate-acting insulin made by combining insulin with protamine; also called isophane or NPH insulin (Humulin N, Novolin N).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.