Diabetes Mellitus Type IIPhase 3NCT00151697
LANN-study: Lantus, Amaryl, Novorapid, Novomix Study
A Phase 3 study testing Novomix 30, Novorapid and Amaryl and Lantus in people with Diabetes Mellitus Type II, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Diabetes Mellitus Type II
- What is being tested?
- Novomix 30, Novorapid and Amaryl and Lantus
- How many people
- 150 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2005to not given
- Phase
- Phase 3
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- failing maximal oral treatment, defined as mean fasting blood glucose over 8 mmol/l and HbA1C over 7.5% for three months or more
- BMI 25 - 35 kg/m2
- fasting plasma C-peptide level over 0.3 nmol/l
- stable metformin and sulfonylurea dose for at least three months
- stable weight for at least three months (change maximal 2 kg)
Who cannot join
- fasting glucose over 25 mmol/l
- use of alpha-glucosidase inhibitors or thiazolidinediones in the two months preceding the study
- renal or liver failure defined as serum creatinine over 150 micromol/l, liver enzymes over 1.5 upper normal limit
- heart failure
- pregnancy
- alcohol more than two units per day
Show all 10Show fewer
- inflammatory or infectious diseases
- unstable chronic disease
- discontinuation of smoking within three months of randomisation date
- allergy for or intolerance of glimepiride or novorapid.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: New Approach to Treat Type II Diabetes Failing on Maximal Oral Treatment
Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments.
Read the detailed description
Diabetic patients failing on maximal oral treatment usually switch to twice daily administration of a mixture of short- and longacting insulin. Although this improves glycemic control, it is generally accompanied by a substantial gain in body weight. This may lead to an increase in body fat resulting in a worsening of insulin resistance, leading to an increase in insulin dose needed to maintain glycemic control.
The combination of glimepiride(amaryl) and short-acting insulin (novorapid) is thought to attain glycemic control with a smaller increase in body weight.
In this randomized controlled trial, 150 diabetics failing on maximal oral treatment will be randomized to preprandial use of Novorapid combined with Amaryl at 20.00 hours, twice daily Novomix 30, or once daily Lantus. Metformin will be continued.
In the year after randomisation, patients will be followed for glycemic control, body weight, body composition, recorded number of hypoglycemic events, plasma lipid levels, basal and stimulated C-peptide levels and adverse effects.
- Conditions
- Diabetes Mellitus Type II
- Being tested
- Novomix 30, Novorapid and Amaryl, Lantus
- Keywords
- diabetes, failing oral treatment, weight gain
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus, Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novomix 30Drug
Novorapid and AmarylDrug
LantusDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
glycemic control based on HbA1c
Body weight
Secondary outcomes (8)
8-point glucose day curve of three consecutive days
24-hour glycemic control measured by continuous glucose monitoring for three consecutive days
recorded number of hypoglycemic events per month
waist circumference
dexa measurements of body composition
plasma lipid levels
basal and stimulated C-peptide levels
adverse effects
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus Type IIStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hans de Boer, MD, PhD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151697
- Sponsor's protocol ID
- LTC 297-161104
- Status last verified
- Aug 2011
- First submitted
- 8 Sep 2005
- Last updated
- 9 Aug 2011
- Results posted
- No
Publications
de Boer H, Jansen M, Koerts J, Verschoor L. Prevention of weight gain in type 2 diabetes requiring insulin treatment. Diabetes Obes Metab. 2004 Mar;6(2):114-9. doi: 10.1111/j.1463-1326.2004.00322.x.
PubMed 14746576
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Approach to Treat Type II Diabetes Failing on Maximal Oral Treatment
- ClinicalTrials.gov ID
- NCT00151697
- Acronym / sponsor ID
- LTC 297-161104
- Conditions
- Diabetes Mellitus Type II
- Keywords
- diabetes, failing oral treatment, weight gain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- May 2005
- First posted
- 9 Sep 2005 (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.
Many diabetics gain weight while on insulin therapy. In this study, we evaluate the efficacy of the combination of glimepiride and short-acting insulin on weight control and glucose control. In this study, 150 diabetics whose diabetic control is inadequate while on maximal oral treatment will be randomized to either the new combination treatment or twice daily injections with a mixture of short- and longacting insulin or once-daily injection with a basal insulin analog. The study will compare glucose control and weight gain during a year after randomisation between the three treatments.
Detailed description
Diabetic patients failing on maximal oral treatment usually switch to twice daily administration of a mixture of short- and longacting insulin. Although this improves glycemic control, it is generally accompanied by a substantial gain in body weight. This may lead to an increase in body fat resulting in a worsening of insulin resistance, leading to an increase in insulin dose needed to maintain glycemic control.
The combination of glimepiride(amaryl) and short-acting insulin (novorapid) is thought to attain glycemic control with a smaller increase in body weight.
In this randomized controlled trial, 150 diabetics failing on maximal oral treatment will be randomized to preprandial use of Novorapid combined with Amaryl at 20.00 hours, twice daily Novomix 30, or once daily Lantus. Metformin will be continued.
In the year after randomisation, patients will be followed for glycemic control, body weight, body composition, recorded number of hypoglycemic events, plasma lipid levels, basal and stimulated C-peptide levels and adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- failing maximal oral treatment, defined as mean fasting blood glucose over 8 mmol/l and HbA1C over 7.5% for three months or more
- BMI 25 - 35 kg/m2
- fasting plasma C-peptide level over 0.3 nmol/l
- stable metformin and sulfonylurea dose for at least three months
- stable weight for at least three months (change maximal 2 kg)
Key exclusion criteria (10 listed)
- fasting glucose over 25 mmol/l
- use of alpha-glucosidase inhibitors or thiazolidinediones in the two months preceding the study
- renal or liver failure defined as serum creatinine over 150 micromol/l, liver enzymes over 1.5 upper normal limit
- heart failure
- pregnancy
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 |
|---|---|---|
| Novomix 30 | Drug | – |
| Novorapid and Amaryl | Drug | – |
| Lantus | Drug | – |
Primary outcome
glycemic control based on HbA1c
Body weight
8 secondary outcomes
8-point glucose day curve of three consecutive days
24-hour glycemic control measured by continuous glucose monitoring for three consecutive days
recorded number of hypoglycemic events per month
waist circumference
dexa measurements of body composition
plasma lipid levels
basal and stimulated C-peptide levels
adverse effects
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 9 Aug 2011.
- Background: PubMed 14746576de Boer H, Jansen M, Koerts J, Verschoor L. Prevention of weight gain in type 2 diabetes requiring insulin treatment. Diabetes Obes Metab. 2004 Mar;6(2):114-9. doi: 10.1111/j.1463-1326.2004.00322.x.
Related trials for Diabetes Mellitus Type II
Recruiting
Using Ultromics EchoGo HFpEF Algorithm to Identify and Treat High Heart Failure Risk in Patients With Type 2 Diabetes
Heart Failure, Diabetes
Recruiting
Continuous Glucose Monitoring Systems in People With Type 2 Diabetes Not Treated With Insulin
Type 2 Diabetes
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
Active, not recruitingObservational study
An Observational Study to Learn More About How Safe Finerenone is and How Well it Works in Indian People With Chronic Kidney Disease and Type 2 Diabetes in Routine Medical Practice
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
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.
Hans de Boer, MD, PhD principal investigator
Rijnstate Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Novomix 30, Novorapid and Amaryl and Lantus in people with Diabetes Mellitus Type II, run by Rijnstate Hospital at 1 site in Netherlands.
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 5 inclusion and 10 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 9 Aug 2011. 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 Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
glycemic control based on HbA1c. The study lists 2 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 NCT00151697, which also lists 1 linked publication.
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 9 Aug 2011.