A Study of Postprandial Hyperglycemia in Participants With Type 2 Diabetes

NCT01159938 | Completed Phase 4 Results

• 2 other identifiers: 13087F3Z-EW-IOPT
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This Study is looking at whether high blood glucose levels after a meal affect arterial stiffness more or less than low blood glucose levels, and whether certain cardiovascular markers influence the outcome of this.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (5)

• Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast

  The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.

  30 mins (pre-breakfast)

• Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast

  The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.

  60 mins (post-breakfast)

• Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast

  The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.

  120 mins (post-breakfast)

• Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast

  The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.

  180 mins (post-breakfast)

• Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast

  The PWV measured arterial stiffness in the aortic and brachial arteries of T2DM participants. The Least Square (LS) mean was estimated from a mixed-effect analysis of covariance (ANCOVA) model that was adjusted for age, body mass index (BMI), visit, group, condition, group by condition, and random participant.

  240 mins (post-breakfast)

Secondary Outcomes (5)

• Change in Pulse Wave Amplitude (PWA)

  30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)

• Change in Peripheral Artery Tonometry (PAT)

  30 mins (pre-breakfast), 120 and 240 mins (post-breakfast)

• Change in QT Interval on Electrocardiogram (ECG)

  30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)

• Change in Blood Glucose (BG)

  30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast)

• Change in Postprandial Pulse Wave Velocity (PWV)

  30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)

Study Arms (3)

T2DM, albuminuria but normal kidney function

EXPERIMENTAL

Drug: Lispro

Healthy participants

NO INTERVENTION

T2DM, normal urinary albumin excretion rate (UAER)

EXPERIMENTAL

Drug: Lispro

Interventions

Lispro DRUG

Dosage based on participants with type 2 diabetes mellitus (T2DM) normal morning insulin dose and energy content of participant's normal breakfast. Subcutaneous injection given on one occasion. Administered once on low post prandial day.

Also known as: Humalog, LY275585

T2DM, albuminuria but normal kidney function; T2DM, normal urinary albumin excretion rate (UAER)

Eligibility Criteria

• Age: 45 Years - 70 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are diagnosed with T2DM (according to the American Diabetes Association classification \[American Diabetes Association 2006\]) and on insulin therapy for at least 6 months.
• Have not smoked in the last 12 hours prior to the study visit.
• Have albuminuria but normal kidney function or normal UAER \[UAER \< 20 micrograms per minute (mcg/min) or \< 30 milligrams/24 hours (mg/24h), respectively\]. Participants with or without albuminuria but normal kidney function will be matched for age and body mass index (BMI).
• Participants have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
• Each participant must understand the nature of the study and must sign an informed consent document (ICD).
• Healthy participants are eligible to be included in the study only if they meet all of the following criteria:
• Healthy participants 45 to 70 years of age, matched for age and BMI, who have not smoked in the last 12 hours prior to the study.
• Normal glucose tolerance and normal UAER (UAER between \< 20 μg/min in the overnight urine collection or \< 30 mg/24h in the 24-h urine collection).
• Healthy participants have been judged by the investigator to be reliable to keep appointments for clinic visits and all tests and examinations required by the protocol.
• Each healthy participant must understand the nature of the study and must sign an ICD.

You may not qualify if:

• Participants/healthy participants will be excluded from the study if they meet any of the following criteria:
• Have had a cardiovascular event \[stroke, myocardial infarction (MI), coronary artery procedure (by-pass surgery or angioplasty), limb amputation due to ischemia, peripheral vascular disease\] or coronary heart disease confirmed by exercise test or scintigraphy.
• Have arrhythmias.
• Have an acute infection.
• Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
• Are unwilling or unable to comply with the use of a data collection device to directly record data from the participant.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Helsinki, 00014, Finland

Location

Related Publications (3)

• Gordin D, Saraheimo M, Tuomikangas J, Soro-Paavonen A, Forsblom C, Paavonen K, Steckel-Hamann B, Harjutsalo V, Nicolaou L, Pavo I, Koivisto V, Groop PH. Insulin exposure mitigates the increase of arterial stiffness in patients with type 2 diabetes and albuminuria: an exploratory analysis. Acta Diabetol. 2019 Nov;56(11):1169-1175. doi: 10.1007/s00592-019-01351-4. Epub 2019 May 22.

  PMID: 31119456 DERIVED

• Gordin D, Saraheimo M, Tuomikangas J, Soro-Paavonen A, Forsblom C, Paavonen K, Steckel-Hamann B, Vandenhende F, Nicolaou L, Pavo I, Koivisto V, Groop PH. Influence of Postprandial Hyperglycemic Conditions on Arterial Stiffness in Patients With Type 2 Diabetes. J Clin Endocrinol Metab. 2016 Mar;101(3):1134-43. doi: 10.1210/jc.2015-3635. Epub 2016 Jan 5.

  PMID: 26731258 DERIVED

• Muka T, de Jonge EA, Kiefte-de Jong JC, Uitterlinden AG, Hofman A, Dehghan A, Zillikens MC, Franco OH, Rivadeneira F. The Influence of Serum Uric Acid on Bone Mineral Density, Hip Geometry, and Fracture Risk: The Rotterdam Study. J Clin Endocrinol Metab. 2016 Mar;101(3):1113-22. doi: 10.1210/jc.2015-2446. Epub 2015 Dec 18.

  PMID: 26684274 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2010
• First Posted: July 12, 2010
• Study Start: October 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: April 3, 2014
• Results First Posted: April 3, 2014

Record last verified: 2014-02

Locations

FI (1)