Diabetes Mellitus, Type 2Phase 4NCT01159938

A Study of Postprandial Hyperglycemia in Participants With Type 2 Diabetes

A Phase 4 study testing Lispro in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 45 to 70 years, men onlyHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Lispro
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 72 participants
Where: 1 siteFinland
Study dates: Oct 2010to Feb 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 to 70 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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:

Show all 10Show fewer

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Finland1 site

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

Other trials in Finland

About this study

Official title: The Effect of Postprandial Hyperglycemia on the Arterial Stiffness in Patients With Type 2 Diabetes

Conditions: Diabetes Mellitus, Type 2
Being tested: Lispro
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LisproDrug
Also called Humalog, LY275585
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.

Study groups in NCT01159938
Study group	Role	What they receive
T2DM, albuminuria but normal kidney function	Experimental	Not described Receives: Drug: Lispro
Healthy participants	No intervention	Not described
T2DM, normal urinary albumin excretion rate (UAER)	Experimental	Not described Receives: Drug: Lispro

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 240 mins (post-breakfast)

Secondary outcomes (5)

Change in Pulse Wave Amplitude (PWA)
The PWA measured systemic arterial stiffness (augmentation index). PWA was reported as a percentage of systolic peak and calculated as the difference between second and first systolic peak in an ascending aortic pulse pressure waveform divided by the first systolic peak then multiplied by 100. The change in PWA from baseline [30-minute (min) pre-breakfast] is reported.
Measured: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
Change in Peripheral Artery Tonometry (PAT)
The PAT device is a pneumatic plethysmograph that applies uniform pressure to the surface of each finger tip and measures digital pulse amplitude. The PAT was reported as a percentage of pulse amplitude and expressed as the ratio of post deflation to baseline pulse amplitude in hyperemic finger divided by the same ratio in the contralateral finger that served as a control. The change in PAT from baseline [30-minute (min) pre-breakfast] is reported.
Measured: 30 mins (pre-breakfast), 120 and 240 mins (post-breakfast)
Change in QT Interval on Electrocardiogram (ECG)
QT interval is a measure of time from the beginning of the QRS complex to the end of the T wave on an ECG during which contraction of the ventricles occurs. Changes in QT interval from baseline [30-minute (min) pre-breakfast] are reported.
Measured: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
Change in Blood Glucose (BG)
Changes in BG from the baseline [30-minute (min) pre-breakfast] are reported.
Measured: 30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast)
Change in Postprandial Pulse Wave Velocity (PWV)
The PWV measured arterial stiffness in the aortic and brachial arteries of healthy participants and T2DM participants. Changes in PWV from baseline [30-minute (min) pre-breakfast] are reported.
Measured: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2010Feb 2013

First posted12 Jul 2010 (estimated)
Study startOct 2010
Primary completionFeb 2013
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01159938
Sponsor's protocol ID: 13087
Other IDs: F3Z-EW-IOPT
Status last verified: Feb 2014
First submitted: 17 Jun 2010
Last updated: 3 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 31119456
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.
PubMed 26731258
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.
PubMed 26684274

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Postprandial Hyperglycemia on the Arterial Stiffness in Patients With Type 2 Diabetes
ClinicalTrials.gov ID: NCT01159938
Acronym / sponsor ID: 13087
Conditions: Diabetes Mellitus, Type 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 12 Jul 2010 (estimated)
Results: Posted 3 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
T2DM, albuminuria but normal kidney function	Experimental	Drug: Lispro
Healthy participants	No intervention	–
T2DM, normal urinary albumin excretion rate (UAER)	Experimental	Drug: Lispro

Who may qualify

Ages: 45 to 70 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

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).

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
LisproAlso: Humalog, LY275585Dosage 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.	Drug	T2DM, albuminuria but normal kidney function, T2DM, normal urinary albumin excretion rate (UAER)

Primary outcome

Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast
Time frame: 30 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.
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 60 Minutes (Mins) Post-Breakfast
Time frame: 60 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.
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 120 Minutes (Mins) Post-Breakfast
Time frame: 120 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.
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 180 Minutes (Mins) Post-Breakfast
Time frame: 180 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.
Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 240 Minutes (Mins) Post-Breakfast
Time frame: 240 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.

5 secondary outcomes

Change in Pulse Wave Amplitude (PWA)
Time frame: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
Change in Peripheral Artery Tonometry (PAT)
Time frame: 30 mins (pre-breakfast), 120 and 240 mins (post-breakfast)
Change in QT Interval on Electrocardiogram (ECG)
Time frame: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)
Change in Blood Glucose (BG)
Time frame: 30 mins (pre-breakfast), 50, 110 ,170, and 230 mins (post-breakfast)
Change in Postprandial Pulse Wave Velocity (PWV)
Time frame: 30 mins (pre-breakfast), 60, 120, 180 and 240 mins (post-breakfast)

Results and safety

Results posted to the registry on 3 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Healthy Participants	26	26
T2DM With Albuminuria, High to Low	11	11
T2DM With Albuminuria, Low to High	11	10
T2DM With Normal UAER, High to Low	12	12
T2DM With Normal UAER, Low to High	12	12

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

Time frame: 30 mins (pre-breakfast). Least squares mean (95% Confidence Interval). Unit: meters per second (m/s)

Measure	T2DM Overall (High Postprandial Glucose) n = 45	T2DM Overall (Low Postprandial Glucose) n = 45	T2DM With Albuminuria (High Postprandial Glucose) n = 21	T2DM With Albuminuria (Low Postprandial Glucose) n = 22	T2DM With Normal UAER (High Postprandial Glucose) n = 24	T2DM With Normal UAER (Low Postprandial Glucose) n = 23
Aortic PWV (n=44, 44, 21, 22, 23, 22)	10.99 (9.98 to 11.99)	10.73 (9.72 to 11.73)	11.56 (10.08 to 13.04)	11.31 (9.86 to 12.75)	10.41 (9.01 to 11.81)	10.15 (8.71 to 11.59)
Brachial PWV (n=45, 45, 21, 22, 24, 23)	7.49 (7.02 to 7.96)	7.84 (7.37 to 8.30)	7.79 (7.10 to 8.48)	7.99 (7.32 to 8.67)	7.19 (6.54 to 7.84)	7.68 (7.02 to 8.34)

T2DM Overall (High Postprandial Glucose) vs T2DM Overall (Low Postprandial Glucose): LS mean difference: 0.26 (95% CI -0.78 to 1.30), p = 0.617, ANCOVA
T2DM With Albuminuria (High Postprandial Glucose) vs T2DM With Albuminuria (Low Postprandial Glucose): LS Mean Difference: 0.25 (95% CI -1.23 to 1.73), p = 0.732, ANCOVA
T2DM With Normal UAER (High Postprandial Glucose) vs T2DM With Normal UAER (Low Postprandial Glucose): LS Mean Difference: 0.27 (95% CI -1.20 to 1.73), p = 0.715, ANCOVA

Population analysed: Randomized T2DM participants who were scheduled to receive study drug and had a baseline PWV measurement at the specified time point and no major protocol deviation.

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

Time frame: 60 mins (post-breakfast). Least squares mean (95% Confidence Interval). Unit: meters per second (m/sec)

Measure	T2DM Overall (High Postprandial Glucose) n = 45	T2DM Overall (Low Postprandial Glucose) n = 45	T2DM With Albuminuria (High Postprandial Glucose) n = 21	T2DM With Albuminuria (Low Postprandial Glucose) n = 22	T2DM With Normal UAER (High Postprandial Glucose) n = 24	T2DM With Normal UAER (Low Postprandial Glucose) n = 23
Aortic PWV (n= 44, 45, 21, 22, 23, 23)	10.19 (9.38 to 11.00)	10.38 (9.57 to 11.18)	10.26 (9.06 to 11.45)	10.22 (9.06 to 11.38)	10.12 (8.98 to 11.25)	10.53 (9.39 to 11.67)
Brachial PWV (n=45, 45, 21, 22, 24, 23)	7.71 (7.27 to 8.16)	7.80 (7.36 to 8.25)	8.03 (7.37 to 8.69)	8.00 (7.36 to 8.65)	7.39 (6.78 to 8.01)	7.61 (6.98 to 8.23)

T2DM Overall (High Postprandial Glucose) vs T2DM Overall (Low Postprandial Glucose): LS Mean Difference: -0.19 (95% CI -1.10 to 0.72), p = 0.676, ANCOVA
T2DM With Albuminuria (High Postprandial Glucose) vs T2DM With Albuminuria (Low Postprandial Glucose): LS Mean Difference: 0.03 (95% CI -1.27 to 1.34), p = 0.957, ANCOVA
T2DM With Normal UAER (High Postprandial Glucose) vs T2DM With Normal UAER (Low Postprandial Glucose): LS Mean Difference: -0.41 (95% CI -1.68 to 0.85), p = 0.513, ANCOVA

Population analysed: Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.

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

Time frame: 120 mins (post-breakfast). Least squares mean (95% Confidence Interval). Unit: meters per second (m/sec)

Measure	T2DM Overall (High Postprandial Glucose) n = 45	T2DM Overall (Low Postprandial Glucose) n = 45	T2DM With Albuminuria (High Postprandial Glucose) n = 21	T2DM With Albuminuria (Low Postprandial Glucose) n = 22	T2DM With Normal UAER (High Postprandial Glucose) n = 24	T2DM With Normal UAER (Low Postprandial Glucose) n = 23
Aortic PWV (n=45, 44, 21, 22, 24, 22)	10.96 (9.83 to 12.10)	10.76 (9.62 to 11.91)	11.18 (9.50 to 12.87)	10.61 (8.96 to 12.26)	10.74 (9.17 to 12.32)	10.92 (9.28 to 12.56)
Brachial PWV (n=45, 45, 21, 22, 24, 23)	7.66 (7.19 to 8.14)	7.86 (7.38 to 8.34)	7.84 (7.13 to 8.54)	8.03 (7.33 to 8.72)	7.49 (6.83 to 8.16)	7.70 (7.02 to 8.37)

T2DM Overall (High Postprandial Glucose) vs T2DM Overall (Low Postprandial Glucose): LS Mean Difference: 0.20 (95% CI -0.94 to 1.34), p = 0.724, ANCOVA
T2DM With Albuminuria (High Postprandial Glucose) vs T2DM With Albuminuria (Low Postprandial Glucose): LS Mean Difference: 0.57 (95% CI -1.05 to 2.20), p = 0.479, ANCOVA
T2DM With Normal UAER (High Postprandial Glucose) vs T2DM With Normal UAER (Low Postprandial Glucose): LS Mean Difference: -0.18 (95% CI -1.76 to 1.41), p = 0.825, ANCOVA

Population analysed: Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.

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

Time frame: 180 mins (post-breakfast). Least squares mean (95% Confidence Interval). Unit: meters per second (m/sec)

Measure	T2DM Overall (High Postprandial Glucose) n = 45	T2DM Overall (Low Postprandial Glucose) n = 45	T2DM With Albuminuria (High Postprandial Glucose) n = 21	T2DM With Albuminuria (Low Postprandial Glucose) n = 22	T2DM With Normal UAER (High Postprandial Glucose) n = 24	T2DM With Normal UAER (Low Postprandial Glucose) n = 23
Aortic PWV (n= 45, 45, 21, 22, 24, 23)	10.99 (9.99 to 12.00)	11.28 (10.28 to 12.29)	11.04 (9.55 to 12.52)	11.47 (10.01 to 12.94)	10.95 (9.55 to 12.35)	11.09 (9.67 to 12.51)
Brachial PWV (n= 45, 45, 21, 22, 24, 23)	7.75 (7.29 to 8.22)	7.91 (7.45 to 8.38)	7.75 (7.06 to 8.44)	8.32 (7.65 to 9.00)	7.76 (7.11 to 8.41)	7.50 (6.84 to 8.16)

T2DM Overall (High Postprandial Glucose) vs T2DM Overall (Low Postprandial Glucose): LS Mean Difference: -0.29 (95% CI -1.09 to 0.51), p = 0.466, ANCOVA
T2DM With Albuminuria (High Postprandial Glucose) vs T2DM With Albuminuria (Low Postprandial Glucose): LS Mean Difference: -0.44 (95% CI -1.60 to 0.72), p = 0.449, ANCOVA
T2DM With Normal UAER (High Postprandial Glucose) vs T2DM With Normal UAER (Low Postprandial Glucose): LS Mean Difference: -0.15 (95% CI -1.25 to 0.96), p = 0.792, ANCOVA

Population analysed: Randomized T2DM participants who received study drug and had a post-baseline PWV measurement at the specified time point and no major protocol deviation.

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Healthy Participants	0 of 25 (0%)	0 of 25 (0%)	Not reported
T2DM With Albuminuria	0 of 22 (0%)	0 of 22 (0%)	Not reported
T2DM With Normal UAER	0 of 24 (0%)	0 of 24 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31119456Gordin 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.
Derived from this study: PubMed 26731258Gordin 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.
Derived from this study: PubMed 26684274Muka 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

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) study director

Eli Lilly and Company

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lispro in people with Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postprandial Pulse Wave Velocity (PWV) in Type 2 Diabetes Mellitus (T2DM) Participants at 30 Minutes (Mins) Pre-Breakfast (time frame: 30 mins (pre-breakfast)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01159938, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2014.