Diabetes Mellitus, Type 2Phase 3BALLETNCT00515632
Efficacy and Safety of Treatment With Balaglitazone in Type 2 Diabetes Patients on Stable Insulin Therapy
A Phase 3 study testing Balaglitazone in people with Diabetes Mellitus, Type 2, run by Rheoscience A/S at 1 site in Denmark.
Trial summary
Type 2 diabetes mellitus is a metabolic disorder that is primarily characterized by insulin resistance, relative insulin deficiency, and hyperglycemia. People with type 2 diabetes are at high risk of many serious diabetic complications, including cardiovascular disease, blindness, nerve damage and kidney damage. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Balaglitazone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 409 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2007to Oct 2009
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes mellitus, being diagnosed according to the 1999 WHO criteria for at least 3 months
- Age ≥ 18 years
- BMI ≥ 25.0 kg/m2
- HbA1c ≥ 7.0 %
- Treatment with insulin with stable dose of at least 30 U/day (± 4 U/day), for at least 75 days
Who cannot join
- Prior or current use of any PPAR-γ agonist
- Recent use (< 3 months) of an investigational drug
- Pre-existing medical condition judged to preclude safe participation in the study
- Contraindication/intolerance to study medication
- Use of any drug which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
- Diagnosed or receiving medication for heart failure, NYHA I to IV
Show all 17Show fewer
- Hospitalisation for a major CV event in the last 3 months, scheduled major CV intervention
- Uncontrolled treated/untreated systolic blood pressure >180 mmHg and/or diastolic blood pressure > 95 mmHg
- Known diabetic macular oedema
- Hematuria
- Serum creatinine >130 μmol/l
- ALT, AST, total bilirubin or alkaline phosphatase ≥ 2.5 times the upper limit of normal
- Haemoglobin significantly (in the Investigators opinion, but not more than 1 mmol/L) below the lower limit of normal or haemoglobinopathy interfering with valid HbA1c assay
- Pregnancy, breast feeding or planning pregnancy or not using adequate contraceptive methods (adequate contraceptive measures are an intrauterine device or oral contraceptives)
- Mental incapacity, unwillingness, or language barrier precluding adequate understanding or cooperation
- Abuse of alcohol or drugs, or presence of any condition that in the Investigators opinion may lead to poor adherence to study protocols
- Cancer or any clinically significant disease or disorder, except for conditions associated to the type 2 diabetes, which in the Investigator's opinion could interfere with the results of the trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Parallel-group, Placebo and Active Comparator (Pioglitazone)-Controlled Clinical Study to Determine the Efficacy and Safety of Balaglitazone in Patients With Type 2 Diabetes on Stable Insulin Therapy
Type 2 diabetes mellitus is a metabolic disorder that is primarily characterized by insulin resistance, relative insulin deficiency, and hyperglycemia. People with type 2 diabetes are at high risk of many serious diabetic complications, including cardiovascular disease, blindness, nerve damage and kidney damage. Balaglitazone is a thiazolidinedione derivative that is being developed as an oral anti-diabetic drug to improve blood glucose control in patients with type 2 diabetes. The purpose of this study is to assess if additional treatment with balaglitazone in patients with type 2 diabetes on stable insulin treatment will improve blood glucose control and decrease the daily insulin dose compared to placebo, but with less impact on weight gain and oedema than pioglitazone (Actos®) 45 mg.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Balaglitazone
- Keywords
- Type 2 diabetes mellitus on Stable insulin therapy, Balaglitazone, Pioglitazone (Actos®), HbA1c, Weight gain, Oedema, Fasting blood glucose
- Medical subject headings
- Diabetes Mellitus, Type 2, Weight Gain, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BalaglitazoneDrug
One arm balaglitazone 10mg, one arm balaglitazone 20mg, one arm placebo, one arm pioglitazone (Actos®) 45mg, orally taken once daily.
| Study group | Role | What they receive |
|---|---|---|
| Balaglitazone 10 mg per day | Experimental | Not described Receives: Drug: Balaglitazone |
| Balaglitazone 20 mg per day | Experimental | Not described Receives: Drug: Balaglitazone |
| Pioglitazone 45 mg per day | Active comparator | Not described Receives: Drug: Balaglitazone |
| Placebo | Placebo comparator | Not described Receives: Drug: Balaglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c, fasting plasma glucose and 7-point plasma glucose profiles, weight gain, lower leg oedema and safety parameters.
Measured: baseline, 4, 8, 12, 17, 21 and 26 weeks
Secondary outcomes (1)
Waist and hip circumferences, plasmaNT-proBNP, ECG, body composition as measured by DXA, blood lipid profiles, plasma insulin
Measured: baseline and 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionJul 2009
- Study completionOct 2009
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 2Studies 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
- Who is masked
- Participant, Investigator
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rheoscience A/S
- Sponsor type
- University, hospital or other
- Investigators
- Bente J Riis, MD, Study director, Nordic Bioscience Clinical Studies A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00515632
- Sponsor's protocol ID
- DRF2593-307
- Other IDs
- EudraCT No. 2007-002088-29
- Acronym
- BALLET
- Status last verified
- Jul 2010
- First submitted
- 13 Aug 2007
- Last updated
- 23 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Henriksen K, Byrjalsen I, Qvist P, Beck-Nielsen H, Hansen G, Riis BJ, Perrild H, Svendsen OL, Gram J, Karsdal MA, Christiansen C; BALLET Trial Investigators. Efficacy and safety of the PPARgamma partial agonist balaglitazone compared with pioglitazone and placebo: a phase III, randomized, parallel-group study in patients with type 2 diabetes on stable insulin therapy. Diabetes Metab Res Rev. 2011 May;27(4):392-401. doi: 10.1002/dmrr.1187.
PubMed 21328517
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, Placebo and Active Comparator (Pioglitazone)-Controlled Clinical Study to Determine the Efficacy and Safety of Balaglitazone in Patients With Type 2 Diabetes on Stable Insulin Therapy
- ClinicalTrials.gov ID
- NCT00515632
- Acronym / sponsor ID
- BALLET / DRF2593-307
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Type 2 diabetes mellitus on Stable insulin therapy, Balaglitazone, Pioglitazone (Actos®), HbA1c, Weight gain, Oedema, Fasting blood glucose
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Rheoscience A/SUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 14 Aug 2007 (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.
Type 2 diabetes mellitus is a metabolic disorder that is primarily characterized by insulin resistance, relative insulin deficiency, and hyperglycemia. People with type 2 diabetes are at high risk of many serious diabetic complications, including cardiovascular disease, blindness, nerve damage and kidney damage. Balaglitazone is a thiazolidinedione derivative that is being developed as an oral anti-diabetic drug to improve blood glucose control in patients with type 2 diabetes. The purpose of this study is to assess if additional treatment with balaglitazone in patients with type 2 diabetes on stable insulin treatment will improve blood glucose control and decrease the daily insulin dose compared to placebo, but with less impact on weight gain and oedema than pioglitazone (Actos®) 45 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Balaglitazone 10 mg per day | Experimental | Drug: Balaglitazone |
| Balaglitazone 20 mg per day | Experimental | Drug: Balaglitazone |
| Pioglitazone 45 mg per day | Active comparator | Drug: Balaglitazone |
| Placebo | Placebo comparator | Drug: Balaglitazone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Type 2 diabetes mellitus, being diagnosed according to the 1999 WHO criteria for at least 3 months
- Age ≥ 18 years
- BMI ≥ 25.0 kg/m2
- HbA1c ≥ 7.0 %
- Treatment with insulin with stable dose of at least 30 U/day (± 4 U/day), for at least 75 days
Key exclusion criteria (17 listed)
- Prior or current use of any PPAR-γ agonist
- Recent use (< 3 months) of an investigational drug
- Pre-existing medical condition judged to preclude safe participation in the study
- Contraindication/intolerance to study medication
- Use of any drug which in the Investigator's opinion could interfere with the glucose level (e.g. systemic corticosteroids)
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 |
|---|---|---|
| BalaglitazoneOne arm balaglitazone 10mg, one arm balaglitazone 20mg, one arm placebo, one arm pioglitazone (Actos®) 45mg, orally taken once daily. | Drug | Balaglitazone 10 mg per day, Balaglitazone 20 mg per day, Pioglitazone 45 mg per day, Placebo |
Primary outcome
HbA1c, fasting plasma glucose and 7-point plasma glucose profiles, weight gain, lower leg oedema and safety parameters.
Time frame: baseline, 4, 8, 12, 17, 21 and 26 weeks
1 secondary outcome
Waist and hip circumferences, plasmaNT-proBNP, ECG, body composition as measured by DXA, blood lipid profiles, plasma insulin
Time frame: baseline and 26 weeks
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 23 Jul 2010.
- Derived from this study: PubMed 21328517Henriksen K, Byrjalsen I, Qvist P, Beck-Nielsen H, Hansen G, Riis BJ, Perrild H, Svendsen OL, Gram J, Karsdal MA, Christiansen C; BALLET Trial Investigators. Efficacy and safety of the PPARgamma partial agonist balaglitazone compared with pioglitazone and placebo: a phase III, randomized, parallel-group study in patients with type 2 diabetes on stable insulin therapy. Diabetes Metab Res Rev. 2011 May;27(4):392-401. doi: 10.1002/dmrr.1187.
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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.
Bente J Riis, MD study director
Nordic Bioscience Clinical Studies A/S
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 Balaglitazone in people with Diabetes Mellitus, Type 2, run by Rheoscience A/S at 1 site in Denmark.
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 17 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 23 Jul 2010. 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 Denmark. 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. Some participants in this study may receive a placebo. 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?
HbA1c, fasting plasma glucose and 7-point plasma glucose profiles, weight gain, lower leg oedema and safety parameters. (time frame: baseline, 4, 8, 12, 17, 21 and 26 weeks). 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 NCT00515632, 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 23 Jul 2010.