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IV Insulin Protocol in Diabetes and Renal Transplantation
Plain-language guide to NCT00609986: not phased randomized trial of Insulin (regular human) and Insulin Glargine, 104 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00609986
- Phase
- not phased
- Status
- completed
- Start
- 2007-07
- Completion (planned or actual)
- 2010-10
- Participants
- 104 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Kidney Transplantation; Diabetes; Hyperglycemia
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Insulin (regular human) and Insulin Glargine.
Purpose: The purpose of this study is to provide tight blood sugar control using insulin given through the veins at the time of kidney transplantation and up to 3 days after surgery.
After release from the hospital, the patient will control blood sugar with subcutaneous insulin injections or pills.
It had two arms (groups): Intensive (experimental) and Control (active comparator).
The registry classes the interventions as drug.
More on the Plan
Research Design: A randomized control trial comparing intensive intravenous insulin (IVI) for use in the hospital followed by intensive subcutaneous (sc) insulin use for in-patient and out-patient glycemic control will be conducted.
Who Took Part
104 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 18 years of age and greater,. Willing and able to provide informed consent.
The full record lists 3 inclusion and 6 exclusion criteria; among the exclusions: history of an active gi bleed in the previous 3 mos,; scheduled to receive a simultaneous pancreas transplant,; history of a functioning pancreatic transplant,.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Insulin (regular human) study did not mask who received what.
It started in 2007-07 with completion listed for 2010-10.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Delayed Graft Function (time frame: 10 days). Acute/Active Rejection (time frame: 30 months).
It also tracked 2 secondary outcomes, for example Severe Hypoglycemia and Severe Hyperglycemia.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Insulin (regular human) and Insulin Glargine in 104 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Insulin (regular human) compound page and the Insulin Glargine compound page, all human trials.
Our Notes on the Compounds
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
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
- Insulin (regular human) in the library
- Insulin Glargine in the library
- NPH Insulin (isophane) in the library
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.