Type 2 DiabetesPhase 3NexiumNCT00699426
The Effect of Nexium and Probiotics on Insulin Secretion and Cardiovascular Risk Factors in Patients With Type 2 Diabetes
A Phase 3 study testing nexium and Yoghurt in people with Type 2 Diabetes, run by Lise Tarnow.
Trial summary
To test the effect of Nexium and probiotics on insulin secretion and cardiovascular risk factors on type 2 diabetic patients. Study Hypothesis: 1. Nexium causes an increased gastrin secretion that increases the insulin secretion and thereby a reduction of HbA1c 2. Probiotics changes the gut flora and bloodpressure 3. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- nexium and Yoghurt
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to Jun 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetes (WHO criteria) treated with metformin and/or sulfonylureas or diet
- Males and females between 40 and 70 years
- HbA1c between 6,0-10,0
- Diabetes duration > 1 year
Who cannot join
- Kidney disease (s-creatinine above the upper limit of normal range).
- Liver disease (ALAT increase > 3 times the upper limit of the normal range of ALAT).
- Macroalbuminuria (urinary albumin excretion of > 300 mg/day).
- Heart failure(NYHA class lll or lV)
- Severe neuropathy (symptoms + vibration perception threshold > 50 measured by biothesiometer.)
- Neutropenia (neutrophil count<2.0x10/l) or anemia (hemoglobin<8mM for men or <7mM for women.
Show all 17Show fewer
- Alcohol abuse
- Drug abuse
- Severe organic or metabolic diseases including cancer
- C-peptide< 0,3 pmol/l
- Medicine interaction
- Treatment with insulin
- PPI or other medications for ulcus diseases
- Treatment with warfarin or other coumarin derivations
- Pregnant or breastfeeding women
- Allergy to medication used in the study
- Participants may not participate in another clinical intervention trial
About this study
Official title: The Effect of Nexium and Cardi-04 Yoghurt on Insulin Secretion and Effect and Cardi Vascular Risk Factors Associated With the Insulin Syndrome in Patients With Type 2 Diabetes - a Randomized Double-blind, Prospective, Placebo Controlled 2 x 2 Factorial Design 3 Month's Study.
To test the effect of Nexium and probiotics on insulin secretion and cardiovascular risk factors on type 2 diabetic patients.
Study Hypothesis:
- Nexium causes an increased gastrin secretion that increases the insulin secretion and thereby a reduction of HbA1c
- Probiotics changes the gut flora and bloodpressure
- Probiotics causes a change in inflammation and thrombosis.
- Conditions
- Type 2 Diabetes
- Being tested
- nexium, Yoghurt, placebo+placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nexiumDrug
40 mg once daily is tested together with Yoghurt
nexiumDrug
nexium and placebo are tested
YoghurtDietary supplement
Yoghurt
placebo+placeboDrug
placebo and placebo are tested.
| Study group | Role | What they receive |
|---|---|---|
| Nexium + Yoghurt | Active comparator | Not described Receives: Drug: nexium |
| Nexium + Placebo | Placebo comparator | Not described Receives: Drug: nexium |
| Placebo+ Yoghurt | Placebo comparator | Not described Receives: Dietary Supplement: Yoghurt |
| placebo+placebo | Placebo comparator | Not described Receives: Drug: placebo+placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
insulin secretion
Measured: 1 year
Secondary outcomes (1)
blood pressure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionJun 2009
- Study completionJun 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 Type 2 DiabetesStudies 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
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lise Tarnow
- Sponsor type
- University, hospital or other
- Collaborators
- Novo Nordisk A/S, Novonesis, Statens Serum Institut, Steno Diabetes Center Copenhagen
- Responsible party
- Sponsor-investigator, Lise Tarnow, Steno Diabetes Center Copenhagen
- Investigators
- Allan A. Vaag, MD, DMSc, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699426
- Sponsor's protocol ID
- EudraCT: 2007-00405237
- Acronym
- Nexium
- Status last verified
- Aug 2012
- First submitted
- 16 Jun 2008
- Last updated
- 3 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hove KD, Brons C, Faerch K, Lund SS, Petersen JS, Karlsen AE, Rossing P, Rehfeld JF, Vaag A. Effects of 12 weeks' treatment with a proton pump inhibitor on insulin secretion, glucose metabolism and markers of cardiovascular risk in patients with type 2 diabetes: a randomised double-blind prospective placebo-controlled study. Diabetologia. 2013 Jan;56(1):22-30. doi: 10.1007/s00125-012-2714-y. Epub 2012 Sep 26.
PubMed 23011351
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nexium and Cardi-04 Yoghurt on Insulin Secretion and Effect and Cardi Vascular Risk Factors Associated With the Insulin Syndrome in Patients With Type 2 Diabetes - a Randomized Double-blind, Prospective, Placebo Controlled 2 x 2 Factorial Design 3 Month's Study.
- ClinicalTrials.gov ID
- NCT00699426
- Acronym / sponsor ID
- Nexium / EudraCT: 2007-00405237
- Conditions
- Type 2 Diabetes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Lise TarnowUniversity, hospital or other
- Collaborators
- Novo Nordisk A/S, Novonesis, Statens Serum Institut, Steno Diabetes Center Copenhagen
- Study start
- Jun 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 18 Jun 2008 (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.
To test the effect of Nexium and probiotics on insulin secretion and cardiovascular risk factors on type 2 diabetic patients.
Study Hypothesis:
- Nexium causes an increased gastrin secretion that increases the insulin secretion and thereby a reduction of HbA1c
- Probiotics changes the gut flora and bloodpressure
- Probiotics causes a change in inflammation and thrombosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nexium + Yoghurt | Active comparator | Drug: nexium |
| Nexium + Placebo | Placebo comparator | Drug: nexium |
| Placebo+ Yoghurt | Placebo comparator | Dietary Supplement: Yoghurt |
| placebo+placebo | Placebo comparator | Drug: placebo+placebo |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Type 2 diabetes (WHO criteria) treated with metformin and/or sulfonylureas or diet
- Males and females between 40 and 70 years
- HbA1c between 6,0-10,0
- Diabetes duration > 1 year
Key exclusion criteria (17 listed)
- Kidney disease (s-creatinine above the upper limit of normal range).
- Liver disease (ALAT increase > 3 times the upper limit of the normal range of ALAT).
- Macroalbuminuria (urinary albumin excretion of > 300 mg/day).
- Heart failure(NYHA class lll or lV)
- Severe neuropathy (symptoms + vibration perception threshold > 50 measured by biothesiometer.)
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 |
|---|---|---|
| nexium40 mg once daily is tested together with Yoghurt | Drug | Nexium + Yoghurt |
| nexiumnexium and placebo are tested | Drug | Nexium + Placebo |
| YoghurtYoghurt | Dietary supplement | Placebo+ Yoghurt |
| placebo+placeboplacebo and placebo are tested. | Drug | placebo+placebo |
Primary outcome
insulin secretion
Time frame: 1 year
1 secondary outcome
blood pressure
Time frame: 1 year
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 3 Sep 2012.
- Derived from this study: PubMed 23011351Hove KD, Brons C, Faerch K, Lund SS, Petersen JS, Karlsen AE, Rossing P, Rehfeld JF, Vaag A. Effects of 12 weeks' treatment with a proton pump inhibitor on insulin secretion, glucose metabolism and markers of cardiovascular risk in patients with type 2 diabetes: a randomised double-blind prospective placebo-controlled study. Diabetologia. 2013 Jan;56(1):22-30. doi: 10.1007/s00125-012-2714-y. Epub 2012 Sep 26.
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
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.
Allan A. Vaag, MD, DMSc principal investigator
Steno Diabetes Center Copenhagen
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing nexium and Yoghurt in people with Type 2 Diabetes, run by Lise Tarnow.
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 4 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 3 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
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?
insulin secretion (time frame: 1 year). 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 NCT00699426, 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 3 Sep 2012.