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Long-Term Effects of Insulin Plus Metformin Regimens on the Overall and Postprandial Glycemic Control of Patients With Type 2 Diabetes
Plain-language guide to NCT00191464: phase 4 randomized trial of Insulin Glargine and Insulin Lispro, 320 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00191464
- Phase
- phase 4
- Status
- completed
- Start
- 2003-12
- Completion (planned or actual)
- 2005-09
- Participants
- 320
- 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 4 trial, researchers set out to test Insulin Glargine and Insulin Lispro.
The registry classes the interventions as drug.
Who Took Part
The registry lists 320 planned participants were the target.
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: Have type 2 diabetes (World Health Organization \[WHO\] classification. Have clinically acceptable LDL-C, in the investigator's opinion, at Visit 1.
The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: have known metabolic or lactic acidosis; have cardiac disease with functional status that is class iii or iv.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
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.
The Insulin Glargine group and the comparison group ran side by side rather than switching.
Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2003-12 with completion listed for 2005-09.
It ran at 7 sites in United States (1), Australia (1), Greece (1), India (1), Netherlands (1) and Poland (1).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): HbA1C.
It also tracked 26 secondary outcomes, for example General inflammation (hsCRP), High-density lipoprotein cholesterol, Total cholesterol, Triglycerides, Estimates of low-density lipoprotein cholesterol and Nuclear magnetic resonance [NMR] analysis of lipids.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 320 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 Insulin Lispro 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.
Insulin Lispro: A rapid-acting mealtime insulin analog; brands include Humalog, Admelog and Lyumjev.
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.