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Chronic Reduction of Fasting Glycaemia With Insulin Glargine Improves First and Second Phase Insulin Secretion in Patients With Type 2 Diabetes
Plain-language guide to NCT01249677: phase 4 interventional trial of Insulin Glargine, 14 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01249677
- Phase
- phase 4
- Status
- completed
- Start
- 2009-01
- Completion (planned or actual)
- 2010-05
- Participants
- 14 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin Glargine.
Glucose-induced insulin secretion is often diminished in hyperglycaemic patients with type 2 diabetes.
It had 1 arm (groups): insulin glargine (experimental).
Patients with type 2 diabetes on previous therapy with metformin were examined before and after eight weeks of treatment with insulin glargin, aimed to normalize fasting plasma glycaemia.
The registry classes the interventions as drug.
More on the Plan
14 patients with type 2 diabetes on previous metformin therapy were examined before and after eight weeks of treatment with insulin glargine, aimed to normalize fasting glycaemia.
Intravenous glucose tolerance tests were performed with and without previous adjustment of fasting glucose levels by means of a 3-hour intravenous insulin infusion.
Who Took Part
14 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age between 18 and 75 years, inclusive. BMI-range 27-50 kg/m².
The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: patients are undergoing therapy for a malignancy, other than basal cell or squamous cell skin cancer.
How the Study Was Run
It was run as a single-group and open-label study.
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 2009-01 with completion listed for 2010-05.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 4 trial of Insulin Glargine in 14 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.