A Study of Postprandial Hyperglycemia in Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01159938
First received: June 17, 2010
Last updated: March 21, 2013
Last verified: March 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Lispro |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label |
| Official Title: | The Effect of Postprandial Hyperglycemia on the Arterial Stiffness in Patients With Type 2 Diabetes |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
Primary Outcome Measures:
- Change in Postprandial Pulse Wave Velocity (PWV) in patients with albuminuria but normal kidney function [ Time Frame: 30 mins (pre-breakfast) ] [ Designated as safety issue: No ]
- Change in Postprandial Pulse Wave Velocity (PWV) in patients with albuminuria but normal kidney function [ Time Frame: 60 mins (post breakfast) ] [ Designated as safety issue: No ]
- Change in Postprandial Pulse Wave Velocity (PWV) in patients with albuminuria but normal kidney function [ Time Frame: 120 mins (post breakfast) ] [ Designated as safety issue: No ]
- Change in Postprandial Pulse Wave Velocity (PWV) in patients with albuminuria but normal kidney function [ Time Frame: 180 mins (post breakfast) ] [ Designated as safety issue: No ]
- Change in Postprandial Pulse Wave Velocity (PWV) in patients with albuminuria but normal kidney function [ Time Frame: 240 mins (post breakfast) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in Pulse Wave Amplitude (PWA) [ Time Frame: 30 mins (pre-breakfast), and 60, 120, 180 and 240 mins (post-breakfast) ] [ Designated as safety issue: No ]
- Change in Peripheral Artery Tonometry (PAT) [ Time Frame: 30 mins (pre-breakfast), and 120 and 240 mins (post-breakfast) ] [ Designated as safety issue: No ]
- Change in R wave on Electrocardiogram (ECG) [ Time Frame: 30 mins (pre-breakfast), and 60, 120, 180 and 240 mins (post-breakfast) ] [ Designated as safety issue: No ]
- Change in Blood Glucose (BG) [ Time Frame: 30 mins (pre-breakfast), and 50, 110, 170 and 230 mins (post-breakfast) ] [ Designated as safety issue: No ]
- Change in Postprandial Pulse Wave Velocity (PWV) in patients with normal UAER (urinary albumin excretion rate) and healthy volunteers [ Time Frame: 30 mins (pre-breakfast), and 60, 120, 180 & 240 mins (post breakfast) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 73 |
| Study Start Date: | October 2010 |
| Study Completion Date: | February 2013 |
| Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Patients with albuminuria but normal kidney function |
Drug: Lispro
Dosage based on patients normal morning insulin dose and energy content of patients normal breakfast. Subcutaneous injection given on one occasion. Administered once on low post prandial day.
Other Names:
|
| No Intervention: Healthy volunteer | |
| Experimental: Patients with normal UAER |
Drug: Lispro
Dosage based on patients normal morning insulin dose and energy content of patients normal breakfast. Subcutaneous injection given on one occasion. Administered once on low post prandial day.
Other Names:
|
Eligibility| Ages Eligible for Study: | 45 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Are diagnosed with Type 2 Diabetes Mellitus (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 µg/min or < 30 mg/24 hours, respectively). Patients with or without albuminuria but normal kidney function will be matched for age and body mass index (BMI).
- Patients 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 patient must understand the nature of the study and must sign an informed consent document (ICD).
Healthy subjects are eligible to be included in the study only if they meet all of the following criteria:
- Men 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/24 hours in the 24-hour urine collection).
- Healthy subjects 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 subject must understand the nature of the study and must sign an ICD.
Exclusion Criteria:
Patients/healthy subjects 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 subject.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01159938
Locations
| Finland | |
| 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, Finland, 00014 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | 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 |
More Information
No publications provided
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT01159938 History of Changes |
| Other Study ID Numbers: | 13087, F3Z-EW-IOPT |
| Study First Received: | June 17, 2010 |
| Last Updated: | March 21, 2013 |
| Health Authority: | Finland: Finnish Medicines Agency |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Hyperglycemia |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 19, 2013