Trial · NCT02496780

The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients

NCT02496780, Phase 2, Phase 3, Terminated, University of Minnesota; results first posted 2025-03-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients. Trials, record NCT02496780. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02496780

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients
NCT number: NCT02496780
Status: Terminated
Phases: Phase 2, Phase 3
Enrollment: 65 participants, actual
Lead sponsor: University of Minnesota
Conditions: Cystic Fibrosis
Interventions: novolog insulin, levemir insulin, placebo
First posted: 2015-07-14
Last updated: 2025-03-17
Results first posted: 2025-03-17
Limitations and caveats: The study was terminated before reaching the planned sample size, after a futility analysis suggested a full sample size would not lead to a positive result.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Endogenous Protein Breakdown (Flux) After 4 Weeks of Insulin/Placebo Therapy, CF Patients	4 weeks	Primary endpoint. Determined from a stable isotope-labelled test meal. In the primary analysis, patients on both forms of insulin were first combined and compared to CF patients on placebo. In a second analysis, the two insulin types were separately compared to eachother and to placebo. Change in rate of endogenous protein breakdown (Ra-end) change from baseline (pre-treatment) and after 4 wks of study drug
Secondary	Baseline Protein Turnover (Flux), CF Patients vs Healthy Controls	baseline	Endogenous protein breakdown at baseline (Ra-end). CF patients vs healthy controls. Rate of endogenous protein breakdown (Ra-end), nadir (µmol/kg(LBM)/min)

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Endogenous Protein Breakdown (Flux) After 4 Weeks of Insulin/Placebo Therapy, CF Patients	4 weeks	Healthy controls did not participant in the primary aim	µmol/kg(LBM)/min	MEAN
SECONDARY	Baseline Protein Turnover (Flux), CF Patients vs Healthy Controls	baseline	Note that for this secondary endpoint we assessed the baseline data of the entire CF population versus controls. Thus, in this pre-treatment population, all CF patients were included as a group regardless of what arm they were later randomized to. This was the only comparison between CF and healthy controls, who were matched for age, gender and BMI to CF participants.	µmol/kg(LBM)/min	MEAN

Source ClinicalTrials.gov

Results by group5

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Endogenous Protein Breakdown (Flux) After 4 Weeks of Insulin/Placebo Therapy, CF Patients	Placebo	-0.01	Standard Error 0.047	µmol/kg(LBM)/min
Change From Baseline in Endogenous Protein Breakdown (Flux) After 4 Weeks of Insulin/Placebo Therapy, CF Patients	Basal Insulin Levemir	0.022	Standard Error 0.046	µmol/kg(LBM)/min
Change From Baseline in Endogenous Protein Breakdown (Flux) After 4 Weeks of Insulin/Placebo Therapy, CF Patients	Rapid-acting Insulin Novolog	0.0004	Standard Error 0.06	µmol/kg(LBM)/min
Baseline Protein Turnover (Flux), CF Patients vs Healthy Controls	CF Total	0.963	Standard Error 0.135	µmol/kg(LBM)/min
Baseline Protein Turnover (Flux), CF Patients vs Healthy Controls	Healthy Controls	0.921	Standard Error 0.219	µmol/kg(LBM)/min

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	12
Overall Study	STARTED	Basal Insulin Levemir	13
Overall Study	STARTED	Rapid-acting Insulin Novolog	15
Overall Study	STARTED	Healthy Controls	25
Overall Study	COMPLETED	Placebo	11
Overall Study	COMPLETED	Basal Insulin Levemir	9
Overall Study	COMPLETED	Rapid-acting Insulin Novolog	10
Overall Study	COMPLETED	Healthy Controls	20
Overall Study	NOT COMPLETED	Placebo	1
Overall Study	NOT COMPLETED	Basal Insulin Levemir	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events28

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	unable to consume test meal	Gastrointestinal disorders	Placebo	1	12	1
other	unable to consume test meal	Gastrointestinal disorders	Basal Insulin Levemir	1	13	1
other	unable to consume test meal	Gastrointestinal disorders	Rapid-acting Insulin Novolog	0	15	0
other	unable to consume test meal	Gastrointestinal disorders	Healthy Controls	2	25	2
other	vomiting with test meal	Gastrointestinal disorders	Placebo	0	12	0
other	vomiting with test meal	Gastrointestinal disorders	Basal Insulin Levemir	1	13	1
other	vomiting with test meal	Gastrointestinal disorders	Rapid-acting Insulin Novolog	0	15	0
other	vomiting with test meal	Gastrointestinal disorders	Healthy Controls	0	25	0
other	CF pulmonary exacerbation	Respiratory, thoracic and mediastinal disorders	Placebo	0	12	0
other	CF pulmonary exacerbation	Respiratory, thoracic and mediastinal disorders	Basal Insulin Levemir	0	13	0

1 to 10 of 28Source ClinicalTrials.gov

See all 28 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	0	12
Total, all-cause mortality	Basal Insulin Levemir	0	13
Total, all-cause mortality	Rapid-acting Insulin Novolog	0	15
Total, all-cause mortality	Healthy Controls	0	25
Total, other adverse events	Placebo	2	12
Total, other adverse events	Basal Insulin Levemir	4	13
Total, other adverse events	Rapid-acting Insulin Novolog	4	15
Total, other adverse events	Healthy Controls	5	25
Total, serious adverse events	Placebo	0	12
Total, serious adverse events	Basal Insulin Levemir	0	13

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02496780

GET https://conductscience.org/api/trials/v1/NCT02496780/events?page=2

API reference For AI assistants