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Compare Blood Sugar Level Between Lantus in the Morning and Other Insulins in Type 1 Diabetes Adolescents
Plain-language guide to NCT00046501: phase 3 randomized trial of Insulin Glargine and Insulin Lispro, 250 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00046501
- Phase
- phase 3
- Status
- completed
- Start
- 2002-11
- Completion (planned or actual)
- 2005-02
- Participants
- 250
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus
- 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 Insulin Lispro.
The purpose of the study is to compare the effect in blood sugar control between Lantus and twice daily intermediate acting insulins (NPH or Lente) when used as the basal insulin in a multiple daily injection setting with fast acting insulin (Lispro).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 250 planned participants were the target.
It was open to people of any sex aged from 9 years up to 17 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Type 1 diabetes treated with insulin only for at least 1 year,. With a Tanner stage of ≥ 2,.
The full record lists 3 inclusion and 0 exclusion criteria.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Insulin Glargine study: the participants and staff both knew the treatment.
It started in 2002-11 with completion listed for 2005-02.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: to measure change in glycemic control as measured by hemoglobin A1c (A1c) (time frame: from baseline to endpoint (last available post-treatment assessment)).
It also tracked 11 secondary outcomes, for example Change in A1c, Change in fasting self-monitored blood glucose (SMBG) for weekdays, weekends and weekday/weekend combined, Change in urinary spot random microalbumin-to-creatinine (A/C) ratio, Change in 8-point blood glucose profiles for weekdays, weekends, and weekday/weekend combined, Change in glucose and Occurrence of hypoglycemia.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Lispro in 250 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.
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.