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Characteristics of Glargine in Type 2 Diabetics
Plain-language guide to NCT00574912: phase 1 interventional trial of Insulin Glargine, 20 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00574912
- Phase
- phase 1
- Status
- completed
- Start
- 2007-03
- Completion (planned or actual)
- 2009-09
- Participants
- 20 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Insulin Glargine.
It had 1 arm (groups): Placebo then Insulin Glargine (experimental).
The registry classes the interventions as drug.
More on the Plan
One of the reasons for this lack of metabolic control in type 2 DM is the continued relative underutilization of insulin.
Diabetes is an insulin deficient state and requires appropriate physiologic replacement of insulin.
Physiologic replacement of insulin requires a basal component to restrain overnight endogenous glucose production, lipolysis and proteolysis.
The other component involves prandial insulin to regulate post prandial glucose levels.
Who Took Part
20 actual participants took part.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 12 adults (males or females) with type 2 diabetes for at least six (6) months. May be using oral agents (SUs, metformin, acarbose or glitinides) with or without insulin. Age 18-70 years. BMI 27-40 kg/m².
The full record lists 4 inclusion and 6 exclusion criteria; among the exclusions: evidence of hepatic, renal or cardiac failure; abnormal results following screening tests; currently using tzds.
How the Study Was Run
The set-up was single-group and open-label.
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.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2007-03 with completion listed for 2009-09.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Maximum Glucose Infusion Rate (time frame: 24 hours).
What This Means in Plain Language
Put simply, this is a phase 1 trial of Insulin Glargine in 20 people.
Its size is small, so on its own it can only give an early look.
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.
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.