An interventional study of artificial saliva spray (AS) and maritime throat spray (TT) in Xerostomia Due to Hyposecretion of Salivary Gland and Diabetes Mellitus, Type 2, sponsored by Certmedica International GmbH. Completed at 1 site in Italy. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-03-02.
Sponsored by Certmedica International GmbH · Not applicable, Interventional, and Prevention
Among 420 studies in Diabetes Mellitus, Type 2 with a site in Italy — 45 open to participants now, 61 under way, 11 of them phase 3. Diabetes Mellitus, Type 2 · Italy.
Among the 420 studies in Diabetes Mellitus, Type 2 with a site in Italy, this one is the 307th largest by enrollment of the 320 interventional ones that give a count, is one of 23 that started in 2017, is one of 71 with no phase, and was the 251st registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →45 of the 420 studies in Diabetes Mellitus, Type 2 with a site in Italy are open now. Recruiting first, the newest first:
Novo Nordisk A/S · Sites in Italy, United States, Argentina and 13 more countries
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Sites in Italy
Eli Lilly and Company · Sites in Italy, United States, Belgium and 8 more countries
AstraZeneca · Sites in Italy, United States, Argentina and 12 more countries
Pfizer · Sites in Italy, United States, Brazil and 8 more countries
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 30 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.
420 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 2 44 · Phase 3 156 · Phase 4 54
First in 1997; this study’s year is marked. 23 started in 2017.
This study's enrollment of 21 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 319 across the 320 interventional studies, 500 across the 99 observational. Of the 316 that completed or were terminated, 132 (42%) have results posted.
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226 of 420 have an industry lead sponsor. The 10 most frequent:
Certmedica International GmbH is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Certmedica International GmbH has 1 study filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
12 of the studies in Diabetes Mellitus, Type 2 with a site in Italy that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06858878Phase 3AmgenEfficacy and Safety of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight | 2027-01-21 |
| NCT07149610Marche Region Regional Health AgencyConnected Care for Type 2 Diabetes Self-Management | 2026-11-30 |
| NCT03604198Corcept TherapeuticsExtension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome | 2026-12 |
| NCT07783893Marche Region Regional Health AgencyE-Health Literacy Intervention for Bangladeshi Migrants With Type 2 Diabetes in Italy | 2026-12 |
| NCT05759637Istituto Auxologico ItalianoType 2 Diabetes, Obesity and Cortisol Excess | 2026-12-31 |
Among the 420 studies in Diabetes Mellitus, Type 2 with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
In diabetes Type II the xerostomia is a quite frequent symptom. In evaluating the activity of an artificial saliva spray compared to a water gel in patients with Diabetes Type II patients had to follow a three day treatment with each product. Whereas after the first treatment period the two groups had to follow a wash out period of three days before the second treatment period could begin.
The artificial saliva spray reduced the xerostomia and the inflammation or the oral tissue.
In diabetes Type II the xerostomia is a quite frequent symptom. The trial was conducted at a single center. Designed and implementing UNI EN ISO 14155:2012, STROBE statement Version 4 and was in conformity with the guidelines of the Declaration of Helsinki.
The type of study was a randomized, cross over clinical trial to compare two treatments (artificial saliva spray (aldiamed(R) mouth spray) AS vs. (Tonimer(R) Throat Spray) TT .
Twenty one subjects that were part of the epidemiological screening for asymptomatic vascular diseases conducted in the Irwin Lab3 of Spoltore (PE / Italy) The degree of xerostomia for the admission had to be at least > 2 according to a semi-quantal scale (ranging from 0 to 6) and patients already under treatment for xerostomia or with xerostomia score \< 2, suffering from obesity, cancer, drug addiction or alcoholism were excluded.
The patients had to follow a three day treatment with each product. Whereas after the first treatment period the two groups had to follow a wash out period of three days before the second treatment period could begin.
The study consisted of a preliminary selection during screening, the measurement of xerostomia and random allocation, first treatment period, wash out period and finally the second treatment period.
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.
Exclusion 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.
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.
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.
The randomized part of the participants who started first with the artificial saliva spray taking it three times a day for a three days treatment, followed by a wash out phase of 3 days. After wash out phase they take for three days the marine water throat spray taking it three times a day for a three days treatment.
Device: artificial saliva spray (AS) · Other: maritime throat spray (TT)
The randomized part of the participants who started first with the marine water throat spray taking it three times a day for a three days treatment, followed by a wash out phase of 3 days. After wash out phase they take for three days the artificial saliva spray taking it three times a day for a three days treatment.
Device: artificial saliva spray (AS) · Other: maritime throat spray (TT)
cross over design
cross over design
xerostomia
xerostomia was measured according to a semi-quantal visual scale (or VAS; visual analogue scale) ranging from 0 to 6 with intervals of 1 point
Time frame: first day before treatment; change to third day after treatment (day 1+3; 7+9)
stimulated salivary flow
Subject was asked to chew a standard square of medical cotton for one minute rolling the cotton in the mouth in order to collect the saliva. The measure of the flow consisted in weighing the cotton before and after the chewing
Time frame: first day before treatment; change to third day after treatment (day 1+3; 7+9)
antioxidant capacity of saliva (SAT test)
The test utilizes the capacity of thiocyanate (SCN) to react with iron (Fe3+) causing the formation of FE((SCN)6)3-.
Time frame: first day before treatment; changes to third day after treatment (day 1+3; 7+9)
patients preference for treatment AS or TT
question in regard to the preference
Time frame: third day after finalization of the treatment period (day 3; 9)
Ran from Sep 2017 to primary completion in Nov 2017, 1 month.
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 1 month is below that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Certmedica International GmbH