Your session is about to expire
← Back to Search
Ladarixin for Type 1 Diabetes (CONSERVA Trial)
Phase 2
Waitlist Available
Led By Nick Giannoukakis, MD
Research Sponsored by Dompé Farmaceutici S.p.A
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at week 11/12 (visit 3) and 27/28 (visit 4)
Awards & highlights
CONSERVA Trial Summary
This trial is testing a new drug to see if it improves glycemic control in overweight people with type 1 diabetes.
Eligible Conditions
- Type 1 Diabetes
CONSERVA Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at week 11/12 (visit 3)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at week 11/12 (visit 3)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The proportion of responders at week 27/28 (visit 4), with responders defined as "patients with an HbA1c reduction from baseline of ≥0.50% (absolute difference) without episodes of severe hypoglycemia
Secondary outcome measures
Average (previous 3 days) daily insulin requirements (IU/kg/day) assessed at week 11/12 (visit 3) and 27/28 (visit 4)
Glycemic Variability by CGM (previous 7 days): time in range (TIR), time above range (TAR) time below range (TBR), standard deviation and coefficient of variation assessed at week 11/12 (visit 3) and 27/28 (visit 4)
Incidence of Treatment Emergent Adverse Events (TEAEs) recorded from the beginning of study treatment to up to the end of study participation
+2 moreSide effects data
From 2019 Phase 2 trial • 76 Patients • NCT0281483828%
Headache
26%
Viral upper respiratory tract infection
12%
Dyspepsia
12%
Pyrexia
8%
Hypoglycaemia
8%
Oropharyngeal pain
6%
Arthralgia
6%
Abdominal pain upper
6%
Nausea
6%
Dizziness
6%
Upper respiratory tract infection
4%
Emotional distress
4%
Tooth extraction
4%
Insomnia
4%
Constipation
4%
Diarrhoea
4%
Hyperchlorhydria
4%
Vomiting
4%
Oral herpes
4%
Urinary tract infection
4%
Aspartate aminotransferase increased
4%
Dysmenorrhoea
2%
Skin wound
2%
Fall
2%
Alopecia
2%
Contusion
2%
Nipple inflammation
2%
mental disorder
2%
Depression
2%
Ear pain
2%
Asthma
2%
Iron deficiency anaemia
2%
Muscle injury
2%
Ear discomfort
2%
Alanine aminotransferase increased
2%
Anaemia
2%
abdominal discomfort
2%
Joint injury
2%
Ligament sprain
2%
Syncope
2%
Neutropenia
2%
Migrane
2%
Glycosylated haemoglobin increased
2%
Hyperglycaemia
2%
Drug hypersensitivity
2%
Acne
2%
Abdominal pain
2%
Eosinophilia
2%
Dental caries
2%
Gatroesophageal reflux disease
2%
Folliculitis
2%
Hypercholesterolaemia
2%
Back pain
2%
Lymphadenopathy
2%
Dysphagia
2%
Faeces hard
2%
Odynophagia
2%
Pancreatitis chronic
2%
Asthenia
2%
Fatigue
2%
Sensation of foreign body
2%
Cystitis
2%
Ear infection
2%
Eye infection
2%
Gastroenteritis
2%
Gastroeteritis viral
2%
Gingivitis
2%
Infected bite
2%
Iron deficiency
2%
Muscle spasms
2%
Myalgia
2%
Osteoarthritis
2%
Toothache
2%
Laryngitis
2%
Pharyngitis
2%
Tinea pedis
2%
Tonsillitis
2%
Tooth abscess
2%
Gastrointestinal disorder
2%
Clavicle fracture
2%
Viral infection
2%
Alcohol poisoning
2%
Cough
2%
Increased viscosity of upper respiratiory secretion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ladarixin
Placebo
CONSERVA Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LadarixinExperimental Treatment1 Intervention
Ladarixin will be administered orally at the dose of 400 mg b.i.d. for 7 cycles of 14 days with an interval of 14 days off, for a total duration of 26 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo will be administered with the same treatment schedule of the IMP.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ladarixin
2016
Completed Phase 2
~120
Find a Location
Who is running the clinical trial?
Dompé Farmaceutici S.p.ALead Sponsor
49 Previous Clinical Trials
4,532 Total Patients Enrolled
Nick Giannoukakis, MDPrincipal InvestigatorInstitute of Cellular Therapeutics Allergheniy Heath Network
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is eligibility for this research study restricted to people younger than 25 ?
"This clinical trial mandates a minimum age requirement of 21 and caps the maximum permissible age at 65."
Answered by AI
Does Ladarixin present any safety hazards to individuals undergoing treatment?
"Ladarixin is estimated to have a safety score of 2, since it has already been tested for its protective effects but not yet proven effective."
Answered by AI
Is this trial currently open to new participants?
"The clinical trial is currently enrolling as indicated by the data on clinicaltrials.gov; it was originally flagged up on July 27th 2022 and had its last update occur in November 21st 2022."
Answered by AI
Do I fulfill the requirements necessary to partake in this investigation?
"This research project is presently seeking 86 individuals with type 1 diabetes mellitus, aged 21-65. Additional criteria include: a positive diagnosis of autoimmune T1D (e.g., insulin autoantibodies and/or GAD65), adherence to existing ISOC plans, HbA1c >7.5%, evidence of IR (>0.8 U/kg/day) overweight or obese BMI between 24-33 kg/m2, T1D duration greater than one year, detectable fasting C-peptide levels (≥ 0.02 nmol/L), use of self-owned CGM for"
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger