An interventional study of Balanced diet high in Slowly Digestible Starch and Balanced diet low in Slowly Digestible Starch in Type2 Diabetes, sponsored by Mondelēz International, Inc.. Completed at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-05-27.
Sponsored by Mondelēz International, Inc. · Not applicable, Interventional, and Prevention
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Among 414 studies in Diabetes Mellitus, Type 2 with a site in France — 36 open to participants now, 42 under way, 9 of them phase 3. Diabetes Mellitus, Type 2 · France.
Among the 414 studies in Diabetes Mellitus, Type 2 with a site in France, this one is the 328th largest by enrollment of the 336 interventional ones that give a count, is one of 17 that started in 2017, is one of 112 with no phase, and was the 287th registered.
10,382 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,411 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →36 of the 414 studies in Diabetes Mellitus, Type 2 with a site in France are open now. Recruiting first, the newest first:
Institut National de la Santé Et de la Recherche Médicale, France · Sites in France
Ages 18+ · Healthy volunteers
Pfizer · Sites in France, United States, Brazil and 8 more countries
Ages 18+
Novo Nordisk A/S · Sites in France, United States, Argentina and 16 more countries
Ages 18+
Hoffmann-La Roche · Sites in France, United States, Argentina and 19 more countries
Ages 18+
Boehringer Ingelheim · Sites in France, United States, Argentina and 48 more countries
Ages 18+
A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 205 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
414 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 7 · Phase 2 36 · Phase 3 143 · Phase 4 43
First in 2000; this study’s year is marked. 17 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 9 is below the median of 80 across 8,359 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 312 across the 336 interventional studies, 276 across the 78 observational. Of the 335 that completed or were terminated, 132 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
234 of 414 have an industry lead sponsor. The 10 most frequent:
Mondelēz International, Inc. is the lead sponsor of 27 studies on the registry; 2 are open to participants now.
Mondelēz International, Inc. has 4 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
4 of the studies in Diabetes Mellitus, Type 2 with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05882071Boehringer IngelheimNon-interventional Study (NIS) on Sodium-glucose Co-transporter-2 Inhibitors (SGLT2i) Use in France | 2026-11-30 |
| NCT06579404University of CambridgeClosed-loop in Adults With Type 2 Diabetes | 2027-03 |
| NCT06567990Hospices Civils de LyonType 2 DIAbeTes With NAFLD: innOvative Biomarkers of Disease progressioN and clInical outComes | 2027-05-25 |
| NCT06614101University Hospital, ToulouseStudy Enabling the Collection of Clinical Data Necessary for the Second Phase of Development of the Glycemic Measurement Device by Analysis of Exhaled Air | 2027-05-31 |
Add all 4 to your calendar (.ics) → With an account.
Among the 414 studies in Diabetes Mellitus, Type 2 with a site in France, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The study is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS).
The study is a randomized cross-over pilot study. The research hypothesis is that the diet high in SDS content (H-SDS) will lower the daylong glycemic response and improve the glycemic control in patients with type 2 diabetes (T2D) compared to the diet low in SDS content (L-SDS).
8 patients with type 2 diabetic patients will be recruited.
Subjets will have 5 visits:
The selection visit (V1) is required to check whether the patients fulfill inclusion and exclusion criteria for the study.
The visit V2 will include randomization, medical check-up and a dietary interview (LogBook supply with explanations for filling and dietary advice cards for the 1st week of diet). The nurse will insert the CGMS and the patient will receive detailed instructions on wearing the sensor and recorder. The patient will leave the research center with a glucometer, the starchy foods and cereal products adapted for its first week of diet and the associated cooking instruction sheets and menus given by the dietician.
During each day of the first experimental diet period, the patient will take at least four blood glucometer readings per day, and will consume the food products according to a menu plan and the cooking instruction sheets given by the dietician, and fill a dietary record.
After 6 days +/- 1 day, the patient will return to the center (Visit V3) to remove the CGMS, bring back the glucometer and the follow-up LogBook. A Medical check-up will also be performed. Compliance will be assessed using the dietary record of the follow-up LogBook and the return of the uneaten products (weighting). A feedback questionnaire will be completed by each patient to have a global assessment of the diet and to evaluate the feasibility of this type of diet over longer periods.
The wash-out period will then last 2 weeks +/- 3 days. Then a new sequence will start. The visit V4 will be similar to visit V2 with: installation of the CGMS, provision of the LogBook and diet specific information for the second period. The glucometer and starchy foods and cereal products will be supplied to the patients.
During each day of this second diet period, patients will be required to consume starchy foods and cereal products according to a menu plan and cooking instructions provided by the dietician, and fill a dietary record. The patient will realize 4 capillary blood glucose control and will fill the information required in the LogBook.
Finally, Visit V5 will be the last visit. It will include, like for visit V3: removal of CGMS, return of glucometer and follow-up LogBook and a medical check-up . Compliance will be assessed using the dietary record of the follow-up LogBook and the return of the uneaten products (weighting). A feedback questionnaire will be completed by patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
T2D volunteer with:
Exclusion Criteria:
General criteria:
Biological criteria:
Therapeutic and medical criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Balanced diet high in Slowly Digestible Starch
Other: Balanced diet high in Slowly Digestible Starch
Balanced diet low in Slowly Digestible Starch
Other: Balanced diet low in Slowly Digestible Starch
The carbohydrate present in the diet high in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week.
The carbohydrate present in the diet low in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week.
Mean postprandial incremental Area Under the Curve (iAUC), measured by CGMS
The iAUC will be calculated using the trapezoid rule. The iAUC includes all area below the curve and above the fasting concentration, with any area beneath fasting being ignored.
Time frame: minimum 2h to maximum 6h postprandial periods and average value of minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: Minimum glycaemia
Minimum glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: maximum glycaemia
maximum glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: Standard Deviation (SD) from CGMS glycaemia
Standard Deviation (SD) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: Coefficient of Variation (CV) from CGMS glycaemia
Coefficient of Variation (CV) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: MAGE
Mean Amplitude of Glycemic Excursions (MAGE) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: MODDs
Mean Of Daily Differences (MODDs) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: MIME
Mean Indices of Meal Excursions (MIME) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: Time in Range
Mean time spent in the appropriate glycemic range in %
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: ADRR
Average of Daily Risk Ratio (ADRR) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: CONGA
Continuous Overall Net Glycemic Action (CONGA) from CGMS glycaemia
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: hyperglycemia durations
hyperglycemia durations
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: hypoglycemia durations
hypoglycemia durations
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: mean glycemic value
mean glycemic value on relevant time interval
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: incremental AUC
incremental AUC calculated on relevant time interval
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: total AUC
total AUC calculated on relevant time interval, calculated using the trapezoid rule and including all area below the curve
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Glycemic profile parameters: kinetics
Daylong glycaemia kinetics
Time frame: minimum 3 days to a maximum of 6 days of CGMS record
Compliance parameters: mean SDS ingestion
mean SDS ingestion by type of meal and per day
Time frame: maximum of 6 days of LogBook record
Dietary intake evaluation
Dietary record analysis, in g of macronutrient intake
Time frame: After 1 week intervention diet
Dietary record evaluation
Dietary record analysis, in % of total energy intake
Time frame: After 1 week intervention diet
Charaterisation of acceptability to H-SDS diet in free living conditions
Feedback questionnaire
Time frame: After 1 week intervention diet
Plan to share: No
Ran from Aug 2017 to primary completion in Jul 2018, 10 months.
Of 177 industry-sponsored interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 29. This study's 10 months is below that.
Counting every sponsor, half of 2,245 studies reached it within 21 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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Mondelēz International, Inc. →