Type 2 Diabetes MellitusPhase 3NCT00375388
The HOME Trial: Hyperinsulinaemia: the Outcome of Its Metabolic Effects, a Randomized Controlled Trial
A Phase 3 study testing Metformin on top of intensive insulin therapy in people with Type 2 Diabetes Mellitus, run by Bethesda General Hospital, Hoogeveen at 1 site in Netherlands.
Trial summary
The HOME-trial is a prospective, randomized controlled trial. The purpose of this study is to investigate the effects of metformin HCL in patients with type 2 diabetes mellitus intensively treated with insulin on the quality of the metabolic control of diabetes, the daily dose of insulin, the lipid profile, the blood… Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Metformin on top of intensive insulin therapy
- How many people
- 400 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 1998to Oct 2002
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of both sexes (women after menopause, women of child-bearing age after sterilization or if practicing reliable contraception)
- Type 2 DM requiring insulin therapy after failure of maximal oral antidiabetic treatment (glycosylated Hb > 7.5%) and need for exogenous insulin. (No concomitant use of oral antidiabetic agents)
- Being ambulatory
- Age: 30 to 80 years
- Proven absence of Islet Antibodies, if QI < 28 kg/m2
- Insulin therapy 4 times daily (21), or insulin therapy 2 times daily using insulin 'mixtures' (rapidly and slowly acting)
Show all 9Show fewer
- Standard dietary prescription by the dietician
- Absence of keto-acidosis
- Informed consent
Who cannot join
- Congestive heart failure, NYHA-classes III or IV
- Cardiac failure and/or myocardial infarction in the last four months before enrolment
- Other severe organic / systemic disease
- Metformin-induced lactic-acidosis
- Intolerance to metformin hydrochloride
- Renal disease or renal dysfunction
Show all 10Show fewer
- Hypoxic states
- Severe hepatic dysfunction
- Excessive alcohol intake, acute or chronic
- Acute or chronic metabolic acidosis
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Bethesda General Hospital and Bethesda Diabetes Center
Hoogeveen, Drenthe, 7909 AA
About this study
Official title: Study of Metformin HCL in Patients With Type 2 Diabetes Intensively Treated With Insulin: a Treatment Strategy for Insulin Resistance in Type 2 Diabetes Mellitus: a Randomized Controlled Trial
The HOME-trial is a prospective, randomized controlled trial. The purpose of this study is to investigate the effects of metformin HCL in patients with type 2 diabetes mellitus intensively treated with insulin on the quality of the metabolic control of diabetes, the daily dose of insulin, the lipid profile, the blood pressure, the incidence / progression of microvascular and macrovascular complications, and on the qualify of life (Diabetes Health Profile). Early results had been published in Diabetes Care, December 2002, pages 2133-2140.
Read the detailed description
The HOME-trial is a prospective, randomized controlled trial. The purpose of this study is to investigate the effects of metformin HCL in patients with type 2 diabetes mellitus intensively treated with insulin on the quality of the metabolic control of diabetes, the daily dose of insulin, the lipid profile, the blood pressure, the incidence / progression of microvascular and macrovascular complications, and on the qualify of life (Diabetes Health Profile). Early results had been published in Diabetes Care, December 2002, pages 2133-2140.
Phase: Phase III
Study Type: Interventional
Overall Status: No longer recruiting (all patients have finished the study)
Study Start Date 02 January 1998
Study Completion Date October 2002
Study Design:
Study Purpose: Treatment Allocation: 1 randomized 0 non randomized Masking: Double blind Control: Placebo Assignment: Parallel Endpoints: Safety / Efficacy
Primary Outcome:
- To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).
Secondary Outcome:
- To investigate the occurrence of macro- and microvascular complications.
- To investigate the quality of life and to perform a socio-economic evaluation.
Conditions:
Type 2 diabetes mellitus requiring insulin therapy.
Keywords:
Type 2 diabetes mellitus; metformin; randomized; double-blind; placebo-controlled; diabetes regulation
Interventions: Metformin (850 mg) or placebo 1-3 times daily.
Insulin: 4 times daily or 'mixtures' of 30% rapidly and 70% slowly acting insulin, 2 times daily.
Eligibility Criteria (only add main ones)
Inclusion Criteria:
- Patients of both sexes (women after menopause, women of child-bearing age after sterilization or if practicing reliable contraception)
- Type 2 DM requiring insulin therapy after failure of maximal oral antidiabetic treatment (glycosylated Hb > 7.5%) and need for exogenous insulin. (No concomitant use of oral antidiabetic agents)
- Being ambulatory
- Age: 30 to 80 years
- Proven absence of Islet Antibodies, if QI < 28 kg/m2
- Insulin therapy 4 times daily (21), or insulin therapy 2 times daily using insulin 'mixtures' (rapidly and slowly acting)
- Standard dietary prescription by the dietician
- Absence of keto-acidosis
- Informed consent
Exclusion Criteria:
- Congestive heart failure, NYHA-classes III or IV
- Cardiac failure and/or myocardial infarction in the last four months before enrolment
- Other severe organic / systemic disease
- Metformin-induced lactic-acidosis
- Intolerance to metformin hydrochloride
- Renal disease or renal dysfunction
- Hypoxic states
- Severe hepatic dysfunction
- Excessive alcohol intake, acute or chronic
- Acute or chronic metabolic acidosis
Gender: Both
Age: 30 - 80 years
Target Number of Subjects: 400 (200 metformin, 200 placebo)
Central Contact:
Name: Adriaan Kooy , internist - diabetologist Degree: MD, PhD Phone: 0528-286222 Extension: 624 Mail: kooy.a@bethesda.nl
Study Official/ Investigators Name: Adriaan Kooy Degree: MD, PhD Officials Role: Study Principal Investigator
Organizational Affiliation:
Bethesda Hospital Hoogeveen Dr. G.H. Amshoffweg 1 7909 AA Hoogeveen The Netherlands
Locations:
Facility: Bethesda Hospital Hoogeveen City: Hoogeveen State/Province: Drenthe Country: The Netherlands Recruitment Status: No longer recruiting (all patients finished)
Facility: Diaconesses' Hospital Meppel City: Meppel State/Province: Drenthe Country: The Netherlands Recruitment Status: No longer recruiting (all patients finished)
Facility: Hospital Coevorden - Hardenberg City: Coevorden State/Province: Drenthe Country: The Netherlands Recruitment Status: No longer recruiting (all patients finished)
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Metformin on top of intensive insulin therapy
- Keywords
- Type 2 diabetes mellitus, Metformin on top of insulin therapy, Randomized placebo-controlled trial, Diabetes regulation, Daily dose of insulin, Body Weight, Patients with type 2 diabetes, Intensive insulin therapy, Age: 30-80 years, Body mass index, Lipids, Blood Pressure, Endothelial function, Low grade inflammation, Fibrinolysis, Microvascular complications, Macrovascular complications
- Medical subject headings
- Diabetes Mellitus, Type 2, Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metformin on top of intensive insulin therapyDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).
Secondary outcomes (3)
To investigate the occurrence and progression of macro- and microvascular complications.
To investigate the quality of life.
To perform a socio-economic evaluation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2006 (estimated)
- Study startJan 1998
- Study completionOct 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes MellitusStudies 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
- Double blind
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- Bethesda General Hospital, Hoogeveen
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda, LifeScan, Merck KGaA, Darmstadt, Germany, Dupont Merck, Merck Sharp & Dohme LLC, Novo Nordisk A/S
- Investigators
- Adriaan Kooy, MD, PhD, Principal investigator, Bethesda General Hospital and Bethesda Diabetes Center, Hoogeveen, The Netherlands (for address: see above)Coen Stehouwer, MD, PhD, Study director, University Hospital of Maastricht, The Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00375388
- Sponsor's protocol ID
- MET/NL/97.01
- Status last verified
- Sep 2006
- First submitted
- 12 Sep 2006
- Last updated
- 13 Sep 2006
- Results posted
- No
Publications
Wulffele MG, Kooy A, Lehert P, Bets D, Ogterop JC, Borger van der Burg B, Donker AJ, Stehouwer CD. Combination of insulin and metformin in the treatment of type 2 diabetes. Diabetes Care. 2002 Dec;25(12):2133-40. doi: 10.2337/diacare.25.12.2133.
PubMed 12453950Stultiens JMG, Top WMC, Kimenai DM, Lehert P, Bekers O, Stehouwer CDA, Kooy A, Meex SJR. Metformin and high-sensitivity cardiac troponin I and T trajectories in type 2 diabetes patients: a post-hoc analysis of a randomized controlled trial. Cardiovasc Diabetol. 2022 Apr 4;21(1):49. doi: 10.1186/s12933-022-01482-z.
PubMed 35379238Out M, Becker ML, van Schaik RH, Lehert P, Stehouwer CD, Kooy A. A gene variant near ATM affects the response to metformin and metformin plasma levels: a post hoc analysis of an RCT. Pharmacogenomics. 2018 Jun 1;19(8):715-726. doi: 10.2217/pgs-2018-0010. Epub 2018 May 23.
PubMed 29790415Out M, Top WMC, Lehert P, Schalkwijk CA, Stehouwer CDA, Kooy A. Long-term treatment with metformin in type 2 diabetes and vitamin D levels: A post-hoc analysis of a randomized placebo-controlled trial. Diabetes Obes Metab. 2018 Aug;20(8):1951-1956. doi: 10.1111/dom.13327. Epub 2018 May 14.
PubMed 29667290Out M, Kooy A, Lehert P, Schalkwijk CA, Stehouwer CDA. Long-term treatment with metformin in type 2 diabetes and methylmalonic acid: Post hoc analysis of a randomized controlled 4.3year trial. J Diabetes Complications. 2018 Feb;32(2):171-178. doi: 10.1016/j.jdiacomp.2017.11.001. Epub 2017 Nov 8.
PubMed 29174300Out M, Miedema I, Jager-Wittenaar H, van der Schans C, Krijnen W, Lehert P, Stehouwer C, Kooy A. Metformin-associated prevention of weight gain in insulin-treated type 2 diabetic patients cannot be explained by decreased energy intake: A post hoc analysis of a randomized placebo-controlled 4.3-year trial. Diabetes Obes Metab. 2018 Jan;20(1):219-223. doi: 10.1111/dom.13054. Epub 2017 Sep 14.
PubMed 28681986de Jager J, Kooy A, Lehert P, Wulffele MG, van der Kolk J, Bets D, Verburg J, Donker AJ, Stehouwer CD. Long term treatment with metformin in patients with type 2 diabetes and risk of vitamin B-12 deficiency: randomised placebo controlled trial. BMJ. 2010 May 20;340:c2181. doi: 10.1136/bmj.c2181.
PubMed 20488910Kooy A, de Jager J, Lehert P, Bets D, Wulffele MG, Donker AJ, Stehouwer CD. Long-term effects of metformin on metabolism and microvascular and macrovascular disease in patients with type 2 diabetes mellitus. Arch Intern Med. 2009 Mar 23;169(6):616-25. doi: 10.1001/archinternmed.2009.20.
PubMed 19307526
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Metformin HCL in Patients With Type 2 Diabetes Intensively Treated With Insulin: a Treatment Strategy for Insulin Resistance in Type 2 Diabetes Mellitus: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00375388
- Acronym / sponsor ID
- MET/NL/97.01
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus, Metformin on top of insulin therapy, Randomized placebo-controlled trial, Diabetes regulation, Daily dose of insulin, Body Weight, Patients with type 2 diabetes, Intensive insulin therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- Bethesda General Hospital, HoogeveenUniversity, hospital or other
- Collaborators
- Takeda, LifeScan, Merck KGaA, Darmstadt, Germany, Dupont Merck, Merck Sharp & Dohme LLC, Novo Nordisk A/S
- Study start
- Jan 1998
- Study completion
- Oct 2002
- First posted
- 13 Sep 2006 (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 HOME-trial is a prospective, randomized controlled trial. The purpose of this study is to investigate the effects of metformin HCL in patients with type 2 diabetes mellitus intensively treated with insulin on the quality of the metabolic control of diabetes, the daily dose of insulin, the lipid profile, the blood pressure, the incidence / progression of microvascular and macrovascular complications, and on the qualify of life (Diabetes Health Profile). Early results had been published in Diabetes Care, December 2002, pages 2133-2140.
Detailed description
The HOME-trial is a prospective, randomized controlled trial. The purpose of this study is to investigate the effects of metformin HCL in patients with type 2 diabetes mellitus intensively treated with insulin on the quality of the metabolic control of diabetes, the daily dose of insulin, the lipid profile, the blood pressure, the incidence / progression of microvascular and macrovascular complications, and on the qualify of life (Diabetes Health Profile). Early results had been published in Diabetes Care, December 2002, pages 2133-2140.
Phase: Phase III
Study Type: Interventional
Overall Status: No longer recruiting (all patients have finished the study)
Study Start Date 02 January 1998
Study Completion Date October 2002
Study Design:
Study Purpose: Treatment Allocation: 1 randomized 0 non randomized Masking: Double blind Control: Placebo Assignment: Parallel Endpoints: Safety / Efficacy
Primary Outcome:
- To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).
Secondary Outcome:
- To investigate the occurrence of macro- and microvascular complications.
- To investigate the quality of life and to perform a socio-economic evaluation.
Conditions:
Type 2 diabetes mellitus requiring insulin therapy.
Keywords:
Type 2 diabetes mellitus; metformin; randomized; double-blind; placebo-controlled; diabetes regulation
Interventions: Metformin (850 mg) or placebo 1-3 times daily.
Insulin: 4 times daily or 'mixtures' of 30% rapidly and 70% slowly acting insulin, 2 times daily.
Eligibility Criteria (only add main ones)
Inclusion Criteria:
- Patients of both sexes (women after menopause, women of child-bearing age after sterilization or if practicing reliable contraception)
- Type 2 DM requiring insulin therapy after failure of maximal oral antidiabetic treatment (glycosylated Hb > 7.5%) and need for exogenous insulin. (No concomitant use of oral antidiabetic agents)
- Being ambulatory
- Age: 30 to 80 years
- Proven absence of Islet Antibodies, if QI < 28 kg/m2
- Insulin therapy 4 times daily (21), or insulin therapy 2 times daily using insulin 'mixtures' (rapidly and slowly acting)
- Standard dietary prescription by the dietician
- Absence of keto-acidosis
- Informed consent
Exclusion Criteria:
- Congestive heart failure, NYHA-classes III or IV
- Cardiac failure and/or myocardial infarction in the last four months before enrolment
- Other severe organic / systemic disease
- Metformin-induced lactic-acidosis
- Intolerance to metformin hydrochloride
- Renal disease or renal dysfunction
- Hypoxic states
- Severe hepatic dysfunction
- Excessive alcohol intake, acute or chronic
- Acute or chronic metabolic acidosis
Gender: Both
Age: 30 - 80 years
Target Number of Subjects: 400 (200 metformin, 200 placebo)
Central Contact:
Name: Adriaan Kooy , internist - diabetologist Degree: MD, PhD Phone: 0528-286222 Extension: 624 Mail: kooy.a@bethesda.nl
Study Official/ Investigators Name: Adriaan Kooy Degree: MD, PhD Officials Role: Study Principal Investigator
Organizational Affiliation:
Bethesda Hospital Hoogeveen Dr. G.H. Amshoffweg 1 7909 AA Hoogeveen The Netherlands
Locations:
Facility: Bethesda Hospital Hoogeveen City: Hoogeveen State/Province: Drenthe Country: The Netherlands Recruitment Status: No longer recruiting (all patients finished)
Facility: Diaconesses' Hospital Meppel City: Meppel State/Province: Drenthe Country: The Netherlands Recruitment Status: No longer recruiting (all patients finished)
Facility: Hospital Coevorden - Hardenberg City: Coevorden State/Province: Drenthe Country: The Netherlands Recruitment Status: No longer recruiting (all patients finished)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients of both sexes (women after menopause, women of child-bearing age after sterilization or if practicing reliable contraception)
- Type 2 DM requiring insulin therapy after failure of maximal oral antidiabetic treatment (glycosylated Hb > 7.5%) and need for exogenous insulin. (No concomitant use of oral antidiabetic agents)
- Being ambulatory
- Age: 30 to 80 years
- Proven absence of Islet Antibodies, if QI < 28 kg/m2
Key exclusion criteria (10 listed)
- Congestive heart failure, NYHA-classes III or IV
- Cardiac failure and/or myocardial infarction in the last four months before enrolment
- Other severe organic / systemic disease
- Metformin-induced lactic-acidosis
- Intolerance to metformin hydrochloride
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 |
|---|---|---|
| Metformin on top of intensive insulin therapy | Drug | – |
Primary outcome
To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).
3 secondary outcomes
To investigate the occurrence and progression of macro- and microvascular complications.
To investigate the quality of life.
To perform a socio-economic evaluation.
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 13 Sep 2006.
- Results publication: PubMed 12453950Wulffele MG, Kooy A, Lehert P, Bets D, Ogterop JC, Borger van der Burg B, Donker AJ, Stehouwer CD. Combination of insulin and metformin in the treatment of type 2 diabetes. Diabetes Care. 2002 Dec;25(12):2133-40. doi: 10.2337/diacare.25.12.2133.
- Derived from this study: PubMed 35379238Stultiens JMG, Top WMC, Kimenai DM, Lehert P, Bekers O, Stehouwer CDA, Kooy A, Meex SJR. Metformin and high-sensitivity cardiac troponin I and T trajectories in type 2 diabetes patients: a post-hoc analysis of a randomized controlled trial. Cardiovasc Diabetol. 2022 Apr 4;21(1):49. doi: 10.1186/s12933-022-01482-z.
- Derived from this study: PubMed 29790415Out M, Becker ML, van Schaik RH, Lehert P, Stehouwer CD, Kooy A. A gene variant near ATM affects the response to metformin and metformin plasma levels: a post hoc analysis of an RCT. Pharmacogenomics. 2018 Jun 1;19(8):715-726. doi: 10.2217/pgs-2018-0010. Epub 2018 May 23.
- Derived from this study: PubMed 29667290Out M, Top WMC, Lehert P, Schalkwijk CA, Stehouwer CDA, Kooy A. Long-term treatment with metformin in type 2 diabetes and vitamin D levels: A post-hoc analysis of a randomized placebo-controlled trial. Diabetes Obes Metab. 2018 Aug;20(8):1951-1956. doi: 10.1111/dom.13327. Epub 2018 May 14.
- Derived from this study: PubMed 29174300Out M, Kooy A, Lehert P, Schalkwijk CA, Stehouwer CDA. Long-term treatment with metformin in type 2 diabetes and methylmalonic acid: Post hoc analysis of a randomized controlled 4.3year trial. J Diabetes Complications. 2018 Feb;32(2):171-178. doi: 10.1016/j.jdiacomp.2017.11.001. Epub 2017 Nov 8.
- Derived from this study: PubMed 28681986Out M, Miedema I, Jager-Wittenaar H, van der Schans C, Krijnen W, Lehert P, Stehouwer C, Kooy A. Metformin-associated prevention of weight gain in insulin-treated type 2 diabetic patients cannot be explained by decreased energy intake: A post hoc analysis of a randomized placebo-controlled 4.3-year trial. Diabetes Obes Metab. 2018 Jan;20(1):219-223. doi: 10.1111/dom.13054. Epub 2017 Sep 14.
- Derived from this study: PubMed 20488910de Jager J, Kooy A, Lehert P, Wulffele MG, van der Kolk J, Bets D, Verburg J, Donker AJ, Stehouwer CD. Long term treatment with metformin in patients with type 2 diabetes and risk of vitamin B-12 deficiency: randomised placebo controlled trial. BMJ. 2010 May 20;340:c2181. doi: 10.1136/bmj.c2181.
- Derived from this study: PubMed 19307526Kooy A, de Jager J, Lehert P, Bets D, Wulffele MG, Donker AJ, Stehouwer CD. Long-term effects of metformin on metabolism and microvascular and macrovascular disease in patients with type 2 diabetes mellitus. Arch Intern Med. 2009 Mar 23;169(6):616-25. doi: 10.1001/archinternmed.2009.20.
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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.
Adriaan Kooy, MD, PhD principal investigator
Bethesda General Hospital and Bethesda Diabetes Center, Hoogeveen, The Netherlands (for address: see above)
Coen Stehouwer, MD, PhD study director
University Hospital of Maastricht, The Netherlands
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 Metformin on top of intensive insulin therapy in people with Type 2 Diabetes Mellitus, run by Bethesda General Hospital, Hoogeveen 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 9 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 13 Sep 2006. 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?
To investigate the quality of the metabolic control of diabetes and related variables (daily dose of insulin, body weight).. 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 NCT00375388, which also lists 8 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 13 Sep 2006.