HDV-Insulin Lispro for Type 1 Diabetes (OPTI-2 Trial)
Recruiting in Palo Alto (17 mi)
+26 other locations
Overseen ByRuth Weinstock, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Diasome Pharmaceuticlas, Inc.
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The goal of this study is to see if directing insulin to the liver will improve the low blood sugar that sometimes happens when injecting insulin in Type 1 diabetes patients. Participants will use continuous glucose monitoring to measure the sugar levels in their blood, and work with the doctor to find the best doses. One group of patients will get the liver targeting insulin, and the other group will use insulin they normally use for treating Type 1 diabetes. The participant will be part of the study for up to 32 weeks.
Is HDV-Insulin Lispro safe for humans?
Research shows that insulin lispro, including its hepatic-directed version (HDV), is generally safe for humans. Studies involving thousands of patients with diabetes found no significant differences in adverse events compared to regular insulin, and only mild hypoglycemic episodes were commonly reported.
134513What makes the drug HDV-Insulin Lispro unique for treating Type 1 Diabetes?
HDV-Insulin Lispro is unique because it uses a special delivery system that targets the liver more effectively, potentially improving how insulin is distributed in the body compared to regular insulin lispro. This could lead to better blood sugar control with fewer side effects.
2561013Will I have to stop taking my current medications?
The trial requires participants to use the study-provided insulin as their only bolus insulin and insulin degludec as their basal insulin. You cannot use noninsulin glucose-lowering medications other than metformin, and you must stop any weight loss medications or supplements 30 days before the study.
What data supports the idea that HDV-Insulin Lispro for Type 1 Diabetes is an effective drug?
The available research does not provide any data on HDV-Insulin Lispro for Type 1 Diabetes. Instead, the research focuses on the use of stiripentol for Dravet syndrome, a type of epilepsy. Therefore, there is no information here to support the effectiveness of HDV-Insulin Lispro for Type 1 Diabetes.
7891112Eligibility Criteria
This trial is for adults with Type 1 Diabetes who are already using Insulin Degludec. Participants should be willing to monitor their blood sugar continuously and work with doctors on dosing. Specific inclusion and exclusion criteria details were not provided.Inclusion Criteria
My A1C is between 6.5% and 9.0%, and I use 1.25 units or less of insulin per kilogram of my body weight daily.
I have Type 1 diabetes, use insulin, and my C-peptide level is below 0.6 nmol/L.
I am willing to use only the study's insulin for my treatment.
Exclusion Criteria
I am currently taking hydroxyurea.
Participant Groups
The study compares HDV-Insulin Lispro, which targets the liver, against regular Insulin Lispro in managing blood sugar levels in Type 1 diabetes patients over a period of up to 32 weeks.
2Treatment groups
Experimental Treatment
Active Control
Group I: HDV Lispro (HDV-L)Experimental Treatment1 Intervention
Subjects in this arm will use degludec as their daily basal insulin, and HDV-lispro as their bolus insulin
Group II: Lispro (LIS)Active Control1 Intervention
Subjects in this arm will use degludec as their daily basal insulin and lispro as their bolus insulin
HDV-Insulin Lispro is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Insulin Lispro for:
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
🇪🇺 Approved in European Union as Insulin Lispro for:
- Diabetes mellitus
🇨🇦 Approved in Canada as Insulin Lispro for:
- Type 1 diabetes mellitus
- Type 2 diabetes mellitus
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Tekton Research, LLCMcKinney, TX
Tekton Research, LLCSan Antonio, TX
Pasadena Clinical TrialsPasadena, CA
Marvel Clinical ResearchHuntington Beach, CA
More Trial Locations
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Who is running the clinical trial?
Diasome Pharmaceuticlas, Inc.Lead Sponsor
References
Insulin lispro: its role in the treatment of diabetes mellitus. [2017]To introduce a rapid-acting human insulin analog, insulin lispro; to review its pharmacology, therapeutics, pharmacokinetics, dosing guidelines, adverse effects, and drug interactions; and to summarize the clinical trials of its efficacy and safety alone and in comparison with regular human insulin in the treatment of diabetes mellitus.
Lispro analog for treatment of generalized allergy to human insulin. [2019]To evaluate the clinical usefulness of the human insulin analog lispro in a patient with generalized allergy to human insulin.
Lispro insulin as premeal therapy in type 1 diabetes: comparison with Humulin R. [2022]To determine the efficacy, tolerability and safety of the short-acting insulin analogue lispro compared with regular short-acting insulin, Humulin R as premeal therapy in type 1 diabetes mellitus and to assess the safety of lispro administered for one year.
Safety of insulin lispro: pooled data from clinical trials. [2019]The safety of insulin lispro was compared with that of regular human insulin of recombinant DNA origin (Humulin R, Lilly), with special emphasis on the development and progression of the chronic complications of diabetes mellitus in relation to insulin therapy. Ten clinical trials of 3634 patients with type 1 and type 2 diabetes mellitus were analyzed. The primary focus was treatment-emergent adverse events, and the secondary focus was the development and progression of the chronic complications of diabetes. The evaluations were based on pertinent laboratory values, predetermined disease-specific COSTART (coding symbol and thesaurus for adverse event terminology) terms, physician evaluations of patients, and physical examinations. There were no clinically or statistically significant differences in the frequency of treatment-emergent adverse events or progression of retinopathy, neuropathy, or cardiovascular disease reported with each therapy. There was no difference between insulin lispro and Humulin R in the occurrence and progression of kidney disease as measured by changes in serum creatinine levels. Pooled data from clinical studies show that insulin lispro has a safety profile comparable to that of Humulin R.
Safety and efficacy of insulin lispro in patients with diabetes mellitus. [2022]Lispro is a human insulin analogue with a very rapid onset of action, and a shorter duration of activity than soluble insulin. In order to assess the therapeutical value of lispro, we have had an open-label, non-comparative study, for 12 weeks, involving 19 IDDM patients. The treatment regimen with lispro and Humulin N has been adapted depending on each patient characteristics. Patients attended three visits, and the main metabolic control parameters included values of hemoglobin Alc, fasting and postprandial blood glucose monitoring. The patients themselves monitored their blood glucose using a glucometer. The mean age value of 19 patients (8 females and 11 males) was 22.32 (+/- 13.59) years. In patients previously receiving insulin treatment, therapy with lispro insulin significantly reduced postprandial glucose values. Lispro has been administered t.i.d. in 14 patients, and b.i.d. in 5 patients. At visit 1, mean value of HbAlc was 10.32% (+/- 1.63%); at visit 3, mean HbAlc was 9.90% (+/- 1.59%). Total insulin daily dose and the rate of short and long acting insulin did not change from visit 1 to visit 3. There has been reported only one serious adverse event during the study: a ketoacidosis due to a technical dosing error. Ten patients have reported mild hypoglycemic episodes. The outcomes of clinical study and of Quality of Life Questionnaire suggests that lispro--the first human insulin analogue used in humans--is effective, safe, and it is broadening beneficially the spectrum of insulins.
Insulin lispro: a new quick-acting insulin analogue. [2019]Insulin lispro (Humalog) is a biosynthetic insulin analogue in which the positions of proline and lysine are reversed in the C-terminal portion of the B chain. Human insulin readily self-associates into hexamers, which dissociate relatively slowly following subcutaneous injection. In consequence, there is a clinically important delay between the subcutaneous injection of soluble insulin and its maximal pharmacodynamic effect. The clinical development of lispro has been based on minor and elegant manipulation of the amino acid sequence to create an insulin which self associates poorly, and is therefore absorbed more rapidly into the circulation. By virtue of this characteristic, it has a more rapid onset of action than soluble insulin preparations, and a shorter duration of action. Potential clinical benefits include better matching of peak insulin action to food absorption following meals, and better glycaemic control in the immediate post-prandial period together with less risk of hypoglycaemia in the period before the next meal is due. An important practical advantage for patients is that the insulin injection does not have to be taken 30 min before meals, as recommended for soluble insulin, but can instead be given almost immediately before meals.
Concentrations of stiripentol in children and adults with epilepsy: the influence of dose, age, and comedication. [2013]Stiripentol (STP) was approved as an orphan drug in 2007 in Europe as adjunctive therapy with valproic acid (VPA) and clobazam (CLB) for Dravet syndrome. Dravet syndrome is a highly pharmacoresistant form of epilepsy, which starts in early childhood. Data about STP pharmacokinetics and interactions are still limited and in part inconsistent. The aim of our study was to analyze the effect of age, gender, daily STP dose per body weight (milligrams per kilogram), VPA, CLB, and enzyme-inducing antiepileptic drugs on STP concentration-to-dose ratio (CDR), STP clearance, and STP trough concentrations.
Stiripentol in Dravet syndrome: results of a retrospective U.S. study. [2018]To review the efficacy and tolerability of stiripentol in the treatment of U.S. children with Dravet syndrome.
Effectiveness of add-on stiripentol to clobazam and valproate in Japanese patients with Dravet syndrome: additional supportive evidence. [2022]To evaluate the efficacy and safety of stiripentol as add-on therapy in Japanese patients with Dravet syndrome treated with clobazam (CLB) and valproate (VPA).
[Humalog® 200 U/ml KwikPen™]. [2016]Insulin lispro (Humalog®) was the first short-acting insulin analogue to be indicated for the treatment of diabetes mellitus requiring insulin therapy. After subcutaneous injection, insulin lispro has a more favourable pharmacokinetics/pharmacodynamics profile than human insulin, characterized by a faster resorption and a more rapid and less prolonged glucose-lowering activity. These properties allow a better control of postprandial hyperglycaemia and a reduction of the risk of delayed hypoglycaemia, especially at night. The patient's quality of life is also improved because insulin lispro can be injected within the 15 minutes before meal and even possibly after meal when the amount of food intake is unpredictable. Already commercialized as Humalog® 100 U/ml, insulin lispro is now also available as Humalog® 200 U/ml. A pharmacokinetics/pharmacodynamics study confirmed the bioequivalence of the two formulations, based upon the analysis of both plasma free insulin concentrations and glucose infusion rates to maintain normoglycaemia. Humalog® 200 U/ml is available in a novel disposable 3 ml pen (KwikPen™), with lower glide force and injection volume; thus this new pen is more convenient for the patient compared with the current pen used to inject Humalog® 100 U/ml. The new formulation Humalog® 200 U/ml is indicated in Europe for adult patients with type 1 or type 2 diabetes who require more than 20 units of prandial insulin per day to cover their meals.
Patients with dravet syndrome in the era of stiripentol: A French cohort cross-sectional study. [2018]The aim of this study was to assess outcome and seizure response to treatment with stiripentol (STP) associated to valproate (VPA) and clobazam (CLB), which we have used in our center since the 1990s, in patients with Dravet syndrome (DS).
Add-on stiripentol elevates serum valproate levels in patients with or without concomitant topiramate therapy. [2018]Stiripentol (STP), valproate (VPA) and topiramate (TPM) are reported to have efficacy for Dravet syndrome. In this study, we sought to elucidate the mechanisms underlying the increased serum VPA concentrations following STP adjunctive therapy in patients with Dravet syndrome.
Divergent Hypoglycemic Effects of Hepatic-Directed Prandial Insulin: A 6-Month Phase 2b Study in Type 1 Diabetes. [2022]Hepatic-directed vesicle insulin (HDV) uses a hepatocyte-targeting moiety passively attaching free insulin, improving subcutaneous insulin's hepatic biodistribution. We assessed HDV-insulin lispro (HDV-L) versus insulin lispro (LIS) in type 1 diabetes (T1D).