Type 2 Diabetes MellitusPhase 3NCT00975533
Gastric Modulator (TANTALUS® System) Versus Insulin Treatment in Obese Type 2 Diabetic Patients - a Randomized Control Trial
A Phase 3 study testing Tantalus and Insulin in people with Type 2 Diabetes Mellitus, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
This study aims to analyze the pre- and post-operative clinical, hormonal and biochemical changes in moderately obese type 2 diabetic patients who are sub-optimally controlled on at least 2 anti-diabetic agents. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Tantalus and Insulin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- Oct 2009to Oct 2011
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Able to provide written informed consent
- Adult patients aged between 18 and 60 years (inclusive)
- Male or female of Chinese ethnicity
- Type 2 diabetes mellitus with disease duration of greater than 2 and less than 10 years
- severe obesity, includes BMI 25 to 27.5 kg/m and central obesity defined by waist circumference greater than 90 cm in women and greater than 95 in men, or BMI greater than 27.5 to less than 35 kg/m
- HbA1c greater than or equals to 7.5% but less than 10% despite treated with maximum dose or maximally tolerated dose of 2 anti-diabetic drugs (OAD) with good drug compliance
Who cannot join
- On anti-obesity drugs
- On insulin treatment at the time of the recruitment
- On glitazone or incretins (dipeptidyl peptidase-4 inhibitor or glucagons-like peptide-1) treatment
- On any implantable device including cardiac pacing
- Anticipated to have MRI examinations
- Fasting C-peptide level less than 0.5g/L
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- Renal impairment (defined as serum creatinine greater than 150mol/L and/or estimated glomerular filtration rate less than 60 mL/min/1.73m)
- Significant liver impairment (ALT more than 3 times upper limit of normal range)
- Active malignant disease. Patients with malignant disease who have been disease-free for at least 5 years are eligible
- Active infection
- Active and uncontrolled thyroid diseases
- Childbearing age female patients without reliable contraceptive methods
- Life expectancy less than 12 months
- Administration of another investigational drugs or procedures within 4 weeks before screening
- Any medical illness or condition as judged by the investigators as ineligible to participate the study
- Special population, e.g. prisoner, mentally disabled, investigators' student or employees
Trial locations and contacts
1 site in 1 country.
China1 site
Prince of Wales Hospital
Shatin, Hong Kong
Simon KH Wong, MBChB
Alice PS Kong, MBChB
About this study
Official title: A Randomized Study to Evaluate the Efficacy and Acceptability of Laparoscopic Placement of Gastric Modulator (TANTALUS® System) Versus Insulin Treatment in Obese Type 2 Diabetic Patients Sub-optimally Controlled With Oral Anti-diabetic Agents.
This study aims to analyze the pre- and post-operative clinical, hormonal and biochemical changes in moderately obese type 2 diabetic patients who are sub-optimally controlled on at least 2 anti-diabetic agents. Study participants will either receive implantation of the gastric contraction modulator or conventional treatment with insulin therapy.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Tantalus, Insulin
- Keywords
- type 2 diabetes mellitus, obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TantalusDevice
The TANTALUS System is implanted using minimally invasive procedure (laparoscopy). It uses leads with stitch electrodes to deliver electrical signals to the gastric wall for the treatment of obese subjects with T2DM.
InsulinDrug
Insulin treatment will be prescribed, in accordance with the common medical practice at the institute. Dosages will be recorded on a daily basis.
| Study group | Role | What they receive |
|---|---|---|
| Tantalus | Experimental | The TANTALUS System is implanted using minimally invasive procedure (laparoscopy). It uses leads with stitch electrodes to deliver electrical signals to the gastric wall for the treatment of obese subjects with T2DM. The device is intended to improve glycemic control and induce weight loss. Receives: Device: Tantalus |
| Control | Active comparator | Insulin treatment will be prescribed, in accordance with the common medical practice at the institute. Dosages will be recorded on a daily basis. Receives: Drug: Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in body weight before and after interventions at 6 and 12 months
Measured: 6 months and 1 year
changes in HbA1c before and after interventions
Measured: 6 and 12 months
frequency of hypoglycaemia
Measured: 6 month and 1 year
dichotomous composite end point assessing the proportion of patients meeting all of the following prespecified criteria defined as: 1. HbA1c ≤7.0% or an HbA1c reduction from baseline ≥0.5% 2. no weight gain 3. no severe hypoglycaemia
Measured: 6 and 12 months
composite quantitative score calculate from the results of glycemic control, weight response and degree of hypoglycemia
Measured: 6 month and 1 year
Secondary outcomes (7)
waist circumferences
Measured: 6 month and 1 year
insulin secretory responses (as measured by the standard meal test)
Measured: 6 month and 1 year
Hormonal profiles (including gut hormones)
Measured: 6 months and 1 year
a. eating behavior, satiety and quality of life as measured by the Food Frequency Questionnaire, Visual Analogue Rating Scale To Assess Satiety, EDE, SF-36 and GIQOL questionnaires
Measured: 6 month and 1 year
resting energy expenditure as monitored by indirect calorimetry (MedGem).
Measured: 6 month and 1 year
radiological assessment (ultrasound scan and densitometry to measure mesenteric and total body fat respectively)
Measured: 6 months and 1 year
differences in insulin requirement
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 posted11 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2011 (estimated)
- Study completionOct 2011 (estimated)
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 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- MetaCure Limited
- Investigators
- Simon KH Wong, MBChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975533
- Sponsor's protocol ID
- CRE-2008.335
- Status last verified
- Sep 2009
- First submitted
- 10 Sep 2009
- Last updated
- 11 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Wong SK, Kong AP, Luk AO, Ozaki R, Ng VW, Lebovitz HE, Ng EK, Chan JC. A pilot study to compare meal-triggered gastric electrical stimulation and insulin treatment in Chinese obese type 2 diabetes. Diabetes Technol Ther. 2015 Apr;17(4):283-90. doi: 10.1089/dia.2014.0234. Epub 2015 Feb 24.
PubMed 25710812
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Evaluate the Efficacy and Acceptability of Laparoscopic Placement of Gastric Modulator (TANTALUS® System) Versus Insulin Treatment in Obese Type 2 Diabetic Patients Sub-optimally Controlled With Oral Anti-diabetic Agents.
- ClinicalTrials.gov ID
- NCT00975533
- Acronym / sponsor ID
- CRE-2008.335
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- type 2 diabetes mellitus, obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- MetaCure Limited
- Study start
- Oct 2009
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 11 Sep 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.
This study aims to analyze the pre- and post-operative clinical, hormonal and biochemical changes in moderately obese type 2 diabetic patients who are sub-optimally controlled on at least 2 anti-diabetic agents. Study participants will either receive implantation of the gastric contraction modulator or conventional treatment with insulin therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tantalus | Experimental | Device: TantalusThe TANTALUS System is implanted using minimally invasive procedure (laparoscopy). It uses leads with stitch electrodes to deliver electrical signals to the gastric wall for the treatment of obese subjects with T2DM. The device is intended to improve glycemic control and induce weight loss. |
| Control | Active comparator | Drug: InsulinInsulin treatment will be prescribed, in accordance with the common medical practice at the institute. Dosages will be recorded on a daily basis. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Able to provide written informed consent
- Adult patients aged between 18 and 60 years (inclusive)
- Male or female of Chinese ethnicity
- Type 2 diabetes mellitus with disease duration of greater than 2 and less than 10 years
- severe obesity, includes BMI 25 to 27.5 kg/m and central obesity defined by waist circumference greater than 90 cm in women and greater than 95 in men, or BMI greater than 27.5 to less than 35 kg/m
Key exclusion criteria (16 listed)
- On anti-obesity drugs
- On insulin treatment at the time of the recruitment
- On glitazone or incretins (dipeptidyl peptidase-4 inhibitor or glucagons-like peptide-1) treatment
- On any implantable device including cardiac pacing
- Anticipated to have MRI examinations
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 |
|---|---|---|
| TantalusThe TANTALUS System is implanted using minimally invasive procedure (laparoscopy). It uses leads with stitch electrodes to deliver electrical signals to the gastric wall for the treatment of obese subjects with T2DM. | Device | Tantalus |
| InsulinInsulin treatment will be prescribed, in accordance with the common medical practice at the institute. Dosages will be recorded on a daily basis. | Drug | Control |
Primary outcome
changes in body weight before and after interventions at 6 and 12 months
Time frame: 6 months and 1 year
changes in HbA1c before and after interventions
Time frame: 6 and 12 months
frequency of hypoglycaemia
Time frame: 6 month and 1 year
dichotomous composite end point assessing the proportion of patients meeting all of the following prespecified criteria defined as: 1. HbA1c ≤7.0% or an HbA1c reduction from baseline ≥0.5% 2. no weight gain 3. no severe hypoglycaemia
Time frame: 6 and 12 months
composite quantitative score calculate from the results of glycemic control, weight response and degree of hypoglycemia
Time frame: 6 month and 1 year
7 secondary outcomes
waist circumferences
Time frame: 6 month and 1 year
insulin secretory responses (as measured by the standard meal test)
Time frame: 6 month and 1 year
Hormonal profiles (including gut hormones)
Time frame: 6 months and 1 year
a. eating behavior, satiety and quality of life as measured by the Food Frequency Questionnaire, Visual Analogue Rating Scale To Assess Satiety, EDE, SF-36 and GIQOL questionnaires
Time frame: 6 month and 1 year
resting energy expenditure as monitored by indirect calorimetry (MedGem).
Time frame: 6 month and 1 year
radiological assessment (ultrasound scan and densitometry to measure mesenteric and total body fat respectively)
Time frame: 6 months and 1 year
differences in insulin requirement
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2009.
- Derived from this study: PubMed 25710812Wong SK, Kong AP, Luk AO, Ozaki R, Ng VW, Lebovitz HE, Ng EK, Chan JC. A pilot study to compare meal-triggered gastric electrical stimulation and insulin treatment in Chinese obese type 2 diabetes. Diabetes Technol Ther. 2015 Apr;17(4):283-90. doi: 10.1089/dia.2014.0234. Epub 2015 Feb 24.
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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.
Simon KH Wong, MBChB principal investigator
Chinese University of Hong Kong
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 Tantalus and Insulin in people with Type 2 Diabetes Mellitus, run by Chinese University of Hong Kong at 1 site in China.
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 6 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 11 Sep 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Simon KH Wong, MBChB (852-26322627, wongkhmo@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in body weight before and after interventions at 6 and 12 months (time frame: 6 months and 1 year). The study lists 5 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 NCT00975533, 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 11 Sep 2009.