Trial · Interventional

CompletedPhase 3Results postedRegistry data

Feasibility of Once/Daily Administered GLP/1 Receptoragonist (Lixisenatide) in Combination With Basal Insulin

Short name LixiBIT

NCTNCT02168491Other idLixiBIT_V3Other id2013-005334-37

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 10 participants (actual)
Sponsor: Medical University of Vienna · Other
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
Austria
Start: Nov 2014
Primary completion: Jul 2015
Completion: Aug 2015
First posted: 20 Jun 2014 (estimated)
Last update posted: 9 May 2017
Conditions: Type 2 Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201420152016

Ph 3
LixiBIT
NCT02168491
Nov 2014 to Aug 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

Premixed insulin-based therapy is a standard insulin treatment strategy in Austria. The widespread use of premixed insulin is explained by high acceptance by health care professionals and patients due to one single product and flexible number of injections (1-3 daily) which covers the demand in controlling fasting and postprandial glucose excursions of most patients with diabetes. However, the use of pre-mixed insulin frequently leads to a high insulin demand and consequently weight gain and an increased risk of hypoglycemia. Hence, achieve good metabolic control in these patients remains a major challenge. For those patients, the approach to treatment intensification without facing the typical risks of insulin treatment (hypoglycemia and weight increase) is of major importance. One, so far not exploited option may be the BIT-strategy: Basal insulin in combination with incretin-based therapy. Pathophysiologically basal insulin inhibits glucose production in the liver, decreases hepatic insulin resistance and improves the function of beta cells in the postprandial state by discharge of fasting insulin secretion. During further diabetes progression steadily increasing HbA1c levels - despite good fasting blood glucose control - indicate the need for additional intervention of meal-related glucose excursions. In this stage of type-2 diabetes basal insulin can be combined with prandial (short-acting) insulin or prandial GLP-1 receptor agonists. However, regarding important safety parameters: risks of hypoglycemia and weight gain in the long-term treatment GLP-1 receptor agonists are beneficial. Lixisenatide is a novel GLP-1 receptor agonist with a pronounced postprandial (PPG) effect which fits with basal insulin mode of action primarily focused on fasting blood glucose reduction. Therefore 10 patients (both gender) under treatment with premixed insulin (2-3 times daily) and HbA1c\>7% will be switched to basal insulin glargine (Lantus, once daily) and GLP-1 receptor agonist Lixisenatide (Lyxumia, once daily). The investigators hypothesize that switching from a therapy based on premixed insulin to a simple, once daily administered combination of basal insulin plus a GLP-1 receptor agonist in patients with type-2 diabetes not achieving therapeutic target (HbA1c\>7%) is clinically feasable in an out patient setting

Interventions

LixisenatideDrug
Insulin glargineDrug

Arms1

Experimental
Intervention group
10 type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide

Primary outcomes1

Outcomes the sponsor listed as primary.

Change in HbA1c From Baseline to End
Time frame · 12 weeks
Registry description
A change between two time points is reported. Time Frame: baseline and 12 weeks.

Secondary outcomes(2)

Change in Fasting Plasma Glucose (FPG, Mean Over 2 Weeks)
Time frame · 12 weeks
Registry description
Patients will be instructed to record all insulin injections and a complete 7-point-blood glucose profile (fasting, 2h after breakfast, before lunch, 2h after lunch, before dinner, 2h after dinner, late before going to bed) during a one-week prestudy run-in period to confirm compliance and document current metabolic control and doses of premixed insulin. Patients will be asked to record not only glucose profiles (at least 4 measurements per day) but also the occurrence of hypoglycemic symptoms or other adverse effects daily throughout the study. During the last week of the study patients will be asked to again record a complete 7-point-blood glucose profile (fasting, 2h after breakfast, before lunch, 2h after lunch, before dinner, 2h after dinner, late before going to bed) and drug injections to confirm compliance and document metabolic control.
Change in Body Weight From Baseline to End of Study
Time frame · 12 weeks
Registry description
A change between two time points is reported. Time Frame: baseline and 12 weeks.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 12 weeks

Change in HbA1c From Baseline to End

Group	Value (HbA1c in percent)	Spread
Lixisenatide With Basal Insulin (LixiBIT)	-0.54	0.52

Secondary and other outcome results(2)

Secondary outcomeMean· 12 weeks

Change in Fasting Plasma Glucose (FPG, Mean Over 2 Weeks)

Group	Value (glucose in mg/dl)
Lixisenatide With Basal Insulin (LixiBIT)	-9

Secondary outcomeMean· 12 weeks

Change in Body Weight From Baseline to End of Study

Group	Value (weight in kg)	Spread
Lixisenatide With Basal Insulin (LixiBIT)	-1.4	3.6

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Lixisenatide With Basal Insulin (LixiBIT)Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide	–	1 / 9	3 / 9

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

PubMed tag: none · 2017

Switch to Combined GLP1 Receptor Agonist Lixisenatide with Basal Insulin Glargine in Poorly Controlled T2DM Patients with Premixed Insulin Therapy: A Clinical Observation and Pilot Study in Nine Patients.

Harreiter et al. 2017Diabetes therapy : research, treatment and education of diabetes and related disorderscited by 2

PMID 28357772PMC5446376DOI 10.1007/s13300-017-0249-4PUB-28357772

Free to read · publisher termsCC BY-NC

Read at source

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 70 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: * Age 18 - 70a * Subjects understand study related activities and give written informed concent * HbA1c between 7 - 10 % under treatment with premixed insulin (2-3 injections) Exclusion Criteria: * Females of child-bearing age * History of hypoglycemia unawareness * Gastrointestinal disease associated with prolonged nausea and vomiting * Impaired liver function (transaminase \>2x than normal) * Impaired kidney function (creatinin \> 1,2 mg/dl) * Known intolerance against GLP-1 receptor agonists * History of pancreatitis or pancreas tumor * Malignancies, autoimmune diseases * Severe dyslipidemia (serum triglycerides \> 400 mg/dl, cholesterol \> 300 mg/dl) * Psychiatric disorder * Oral glucose lowering medication except for metformin

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