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Assessment of Duration of Metabolic Effect of a Single Bolus of sc Injected Lantus Compared to NPH Insulin in Patients With Type 2 Diabetes
Plain-language guide to NCT00553020: phase 4 randomized trial of Insulin Glargine, 16 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00553020
- Phase
- phase 4
- Status
- completed
- Start
- 2004-04
- Completion (planned or actual)
- 2005-07
- Participants
- 16 (actual)
- Design
- randomized, single-blind, treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin Glargine.
The registry classes the interventions as drug.
Who Took Part
The registry lists 16 actual participants took part.
It was open to people of any sex aged from 40 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 2 diabetes mellitus of either gender as defined by the American Diabetes Association (3) for more than 6 months. Having required treatment with insulin for at least 6 months. Normal ECG, blood pressure, pulse rate and core body temperature unless the investigator considered an abnormality to be clinically irrelevant and not interfering with the conduct of the study.
The full record lists 8 inclusion and 14 exclusion criteria; among the exclusions: pregnant and nursing women; any condition requiring the regular use of any medication if the regular use of this medication interfered with the study conduct; abuse of alcoholic beverages (as defined in appendix b of the protocol).
How the Study Was Run
It was run as a randomized, crossover and single-blind study.
The participants were allocated by chance, so the Insulin Glargine group and the comparison group should start out alike.
Each person switched between Insulin Glargine and the comparison at some point, usually with a gap in between.
Only one side, usually the participants, was kept unaware of whether Insulin Glargine was given.
Those kept unaware of assignments: participant.
It started in 2004-04 with completion listed for 2005-07.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine in 16 people.
Its size is small, so on its own it can only give an early look.
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, all human trials.
Our Notes on the Compound
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
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.