Diabetes Mellitus Type 2Phase 4NCT00859079
Efficacy of GLP-1 Infusion in Comparison to an Insulin Infusion Protocol to Reach Normoglycemia Type 2 Diabetic Patients
A Phase 4 study testing GLP-1 and Human regular insulin intravenously in people with Diabetes Mellitus Type 2 and Hyperglycemia, run by Medical University of Graz at 1 site in Austria.
Trial summary
The aim of the investigators study was to compare for the first time efficacy and safety of intravenously administered GLP-1 with an established intravenous insulin regimen in hyperglycaemic type 2 diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Diabetes Mellitus Type 2, Hyperglycemia
- What is being tested?
- GLP-1 and Human regular insulin intravenously
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteAustria
- Study dates
- Jun 2006to Jan 2007
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus
- Fasting glycemia above 150 mg/dl
- Signed informed consent
Who cannot join
- Patients with heart failure > NYHA II
- Uncontrolled hypertension
- Impaired kidney function (creatinine > 3 mg/dl)
- Acute infection
Trial locations and contacts
1 site in 1 country.
Austria1 site
Medical University of Graz, Department for Internal Medicine
Graz, 8036
About this study
Official title: Efficacy of a Continuous GLP-1 Infusion in Comparison to a Structured Insulin Infusion Protocol to Reach Normoglycemia in Non-Fasted Type 2 Diabetic Patients
The aim of the investigators study was to compare for the first time efficacy and safety of intravenously administered GLP-1 with an established intravenous insulin regimen in hyperglycaemic type 2 diabetic patients.
Read the detailed description
Intervention studies in patients with acute myocardial infraction or cardiac surgery, using intravenously administered human insulin, suggest that normalization of hyperglycemia can reduce morbidity as well as mortality in these patients. Insulin-based regimens require frequent blood glucose measurements and adjustments of infusion rate to achieve normoglycemia.
In addition, hypoglycaemia is a frequent and important side effect. Glucagon-Like-Peptide 1 (GLP-1) is an insulinotropic, glucagonostatic gastrointestinal hormone that lowers glucose in a glycemia-dependent manner and therefore does not cause hypoglycemia.
The aim of our study was to compare for the first time efficacy and safety of intravenously administered GLP-1 with an established intravenous insulin regimen in hyperglycaemic type 2 diabetic patients.
- Conditions
- Diabetes Mellitus Type 2, Hyperglycemia
- Being tested
- GLP-1, Human regular insulin intravenously
- Keywords
- diabetes mellitus type 2, GLP-1, insulin infusion
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLP-1Drug
Also called GLP-1 infusion (CLINALFA, Laeufelingen, Switzerland)
Patients received GLP-1 intravenously at a dose of 1.2 pmol/kg/min for at maximum 8 hours.
Human regular insulin intravenouslyDrug
Also called Insulin Actrapid, NovoNordisk, Denmark
Human regular insulin intravenously according to the Munich-registry.
| Study group | Role | What they receive |
|---|---|---|
| GLP-1 | Active comparator | Intravenously administered GLP-1 Receives: Drug: GLP-1 |
| Insulin intravenously | Active comparator | Insulin intravenously according to the Munich registry Receives: Drug: Human regular insulin intravenously |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to reach a plasma glucose below 115 mg/dl
Measured: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
Secondary outcomes (2)
plasma glucose after 2 and 4 hours as well as maximum glycemia
Measured: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
number of hypoglycaemic episodes
Measured: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2009 (estimated)
- Study startJun 2006
- Primary completionDec 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies of the same condition, open and under way.
- More trials run by Medical University of GrazThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Investigators
- Thomas C Wascher, MD, Principal investigator, Medical University of Graz, Dept. of Internal Medicine, Auenbruggerpl. 15, 8036 Graz, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00859079
- Sponsor's protocol ID
- TCW-GLP1-1
- Status last verified
- Mar 2009
- First submitted
- 7 Mar 2009
- Last updated
- 10 Mar 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Continuous GLP-1 Infusion in Comparison to a Structured Insulin Infusion Protocol to Reach Normoglycemia in Non-Fasted Type 2 Diabetic Patients
- ClinicalTrials.gov ID
- NCT00859079
- Acronym / sponsor ID
- TCW-GLP1-1
- Conditions
- Diabetes Mellitus Type 2, Hyperglycemia
- Keywords
- diabetes mellitus type 2, GLP-1, insulin infusion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Jun 2006
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 10 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the investigators study was to compare for the first time efficacy and safety of intravenously administered GLP-1 with an established intravenous insulin regimen in hyperglycaemic type 2 diabetic patients.
Detailed description
Intervention studies in patients with acute myocardial infraction or cardiac surgery, using intravenously administered human insulin, suggest that normalization of hyperglycemia can reduce morbidity as well as mortality in these patients. Insulin-based regimens require frequent blood glucose measurements and adjustments of infusion rate to achieve normoglycemia.
In addition, hypoglycaemia is a frequent and important side effect. Glucagon-Like-Peptide 1 (GLP-1) is an insulinotropic, glucagonostatic gastrointestinal hormone that lowers glucose in a glycemia-dependent manner and therefore does not cause hypoglycemia.
The aim of our study was to compare for the first time efficacy and safety of intravenously administered GLP-1 with an established intravenous insulin regimen in hyperglycaemic type 2 diabetic patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GLP-1 | Active comparator | Drug: GLP-1Intravenously administered GLP-1 |
| Insulin intravenously | Active comparator | Drug: Human regular insulin intravenouslyInsulin intravenously according to the Munich registry |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 2 diabetes mellitus
- Fasting glycemia above 150 mg/dl
- Signed informed consent
Key exclusion criteria (4 listed)
- Patients with heart failure > NYHA II
- Uncontrolled hypertension
- Impaired kidney function (creatinine > 3 mg/dl)
- Acute infection
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 |
|---|---|---|
| GLP-1Also: GLP-1 infusion (CLINALFA, Laeufelingen, Switzerland)Patients received GLP-1 intravenously at a dose of 1.2 pmol/kg/min for at maximum 8 hours. | Drug | GLP-1 |
| Human regular insulin intravenouslyAlso: Insulin Actrapid, NovoNordisk, DenmarkHuman regular insulin intravenously according to the Munich-registry. | Drug | Insulin intravenously |
Primary outcome
time to reach a plasma glucose below 115 mg/dl
Time frame: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
2 secondary outcomes
plasma glucose after 2 and 4 hours as well as maximum glycemia
Time frame: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
number of hypoglycaemic episodes
Time frame: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2009.
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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.
Thomas C Wascher, MD principal investigator
Medical University of Graz, Dept. of Internal Medicine, Auenbruggerpl. 15, 8036 Graz, Austria
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 GLP-1 and Human regular insulin intravenously in people with Diabetes Mellitus Type 2 and Hyperglycemia, run by Medical University of Graz at 1 site in Austria.
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 3 inclusion and 4 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 10 Mar 2009. 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 Austria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
time to reach a plasma glucose below 115 mg/dl (time frame: 0,30,60,120,150,180,210,240,270,300,330,360,390,420,450,480,510 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2009.