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EMA Publish Draft Guidelines on Clinical Investigations for Medicinal Products in Diabetes Mellitus

admin — Thu, 27 Oct 2011 15:58:56 +0000

EMA Publish Draft Guidelines on Clinical Investigations for Medicinal Products in Diabetes Mellitus

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Diabetes mellitus is a metabolic disorder characterised by the presence of hyperglycaemia due to defective insulin secretion, insulin action or both. The chronic hyperglycaemia of diabetes mellitus is associated with significant long term sequelae, particularly damage, dysfunction and failure of various organs – especially the kidney, eye, nerves, heart and blood vessels.
Type 1 diabetes is the result of pancreatic beta cell destruction and is prone to acute complications, such as ketoacidosis. In type 1 diabetes the main goal is optimal blood glucose control to be achieved by optimal insulin replacement therapy, extensive education and disease self management. Prevention of complications and management of pregnancy are important issues.
Type 2 diabetes is a complex disorder which involves various degrees of decreased beta-cell function, peripheral insulin resistance and abnormal hepatic glucose metabolism. Glucose control in type 2 diabetes deteriorates progressively over time, and, after failure of diet and exercise alone, needs on average a new intervention with glucose-lowering agents every 3-4 years in order to obtain/retain good control. Despite combination therapy and/or insulin treatment, a sizeable proportion of patients remain poorly controlled.
Overweight, hypertension and hyperlipidaemia are often associated with diabetes mellitus and multiple cardiovascular risk factor intervention is a key issue in type 2 diabetes. Therefore, global treatment aims in management of diabetes mellitus cover both lowering of blood glucose to near normal levels and correcting metabolic abnormalities and cardiovascular risk factors including weight management.

Indeed, it has been shown that normalisation or near normalisation of glucose levels (assessed by changes in HbA1c) in patients with type 1 and type 2 diabetes significantly reduces the risk of microvascular complications (retinopathy, nephropathy and neuropathy); the macrovascular risk reduction in patients with type 2 diabetes is less certain.
In children and adolescents, the diagnosis of diabetes type 1 and type 2 is similar to that in adults; however, the discrimination between them may not always be straightforward. Type 1 diabetes is the predominant form in children. Type 2 diabetes has been recently emerging among – mostly obese – children in puberty and may present with ketoacidosis as the first manifestation of the disease; an obese adolescent with hyperglycaemia may have either type 1 or type 2 diabetes. An important feature of type 2 diabetes in overweight/obese adolescents is the higher insulin resistance and faster beta cell destruction rate relative to adults.
Following may help discriminating between type 1 and type 2 diabetes and monogenic or other genetic non insulin-deficient diabetic forms in children and adolescents:

Disease definitions and methods of diagnosing defined in international treatment guidelines such as ADA recommendations or those of the International Society for Paediatric and Adolescent Diabetes for the diagnosis of diabetes in children and adolescence are based on presence or absence of obesity,
family history,
fasting insulin and C-peptide levels,
auto-antibodies
age of onset

This document provides guidance on clinical development programmes intended to support the registration of new medicinal products for the treatment, delay in onset or prevention of diabetes mellitus or preservation of beta-cell function in patients with diabetes.
These notes are intended to assist applicants during the development phase. Any deviation from guidelines should be explained and justified in the Clinical Overview.
Insulin delivery systems (including pumps, autoinjectors, prefilled syringes, etc.) are outside the scope of this document. Biosimilar insulins are covered by the Annex to Guideline on Similar Biological Medicinal Products containing Biotechnology-Derived Proteins as Active Substance: Non-Clinical and Clinical Issues – Guidance on Similar Medicinal Products containing Recombinant Human Insulin CHMP/32775/05.

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Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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Drug Regulators, EMA (EMEA), Publish draft guidance on Clinical Investigations in the Treatment of Diabetes Mellitus

admin — Fri, 26 Feb 2010 10:33:31 +0000

Drug Regulators, EMA (EMEA), Publish draft guidance on Clinical Investigations in the Treatment of Diabetes Mellitus.

Type 2 diabetes is a complex disorder which involves various degrees of decreased beta-cell function, peripheral insulin resistance and abnormal hepatic glucose metabolism. Glucose control in type 2 diabetes deteriorates progressively over time, and, after failure of diet and exercise alone, needs on average a new intervention with glucose-lowering agents every 3-4 years in order to obtain/retain good control. Despite combination therapy and/or insulin treatment, a sizeable proportion of patients remains poorly controlled.

Overweight, hypertension and hyperlipidaemia are often associated with diabetes mellitus and multiple cardiovascular risk factor intervention is the key issue in type 2 diabetes. Therefore, global treatment aims in management of diabetes mellitus cover both lowering of blood glucose to near normal levels and correcting metabolic abnormalities and cardiovascular risk factors. Indeed, it has been shown that normalisation or near normalisation of glucose levels (assessed by changes in HbA1c) in patients with type 1 and type 2 diabetes significantly reduces the risk of microvascular complications (retinopathy, nephropathy and neuropathy); the macrovascular risk reduction in patients with type 2 diabetes is less certain.

In children and adolescents, the diagnosis of diabetes type 1 and type 2 is similar to that in adults, however, the discrimination between them may not always be straightforward. Type 1 diabetes is the predominant form in children. Type 2 diabetes has been recently emerging among – mostly obese – children in puberty and may present with ketoacidosis as the first manifestation of the disease; an obese adolescent with hyperglycaemia may have either type 1 or type 2 diabetes. An important feature of type 2 diabetes in adolescence is the higher insulin resistance and faster beta cell destruction rate relative to adults.

ADA recommendations for the diagnosis of diabetes in children are based on presence or absence of:
• obesity,
• family history,
• fasting insulin and C-peptide levels,
• auto-antibodies (Diabetes Care, 23(3):381, 2000)
• age of onset
and may help discriminating between type 1 and 2 diabetes in children and adolescents.

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Drug Regulators, EMEA (EMA), Publish a Concept Paper on the Need For Guidance on Clinical Investigations of Medicinal Products in the Treatment of Diabetes Mellitus

admin — Thu, 25 Feb 2010 10:33:17 +0000

Drug Regulators, EMEA (EMA), Publish a Concept Paper on the Need For Guidance on Clinical Investigations of Medicinal Products in the Treatment of Diabetes Mellitus.

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The current CHMP Note for guidance on clinical investigation of medicinal products in the treatment of diabetes mellitus CPMP/EWP/1080/00 was adopted by the CHMP in November 2002. New aspects have emerged since then including:
- Paediatric regulation has been implemented and a need for specific trials in children and adolescents with diabetes is considered.
- A number of new medicines for diabetes have been approved.
- Some medicines have only limited long-term safety data and may be associated with an increased cardiovascular risk.
- The possibility to develop medicines for the prevention of diabetes has been proposed.
- Combination treatment studies, especially with insulin, become more and more complex.
Therefore, the points mentioned above may deserve discussion and a need to update the guidance has been identified.

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Drug Regulators Publish Concept Paper on the Need to Revise Clinical Guidance for Depression

admin — Wed, 11 Nov 2009 14:48:43 +0000

Drug Regulators,EMEA, Publish Concept Paper on the Need to Revise Clinical Guidance for Depression

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Major Depressive Disorder (MDD) is one of the most common psychiatric disorders, which is the fourth leading cause of global disease burden and affects about 15 % of the general population. As outlined in the guidance document MDD is not a benign disorder and risk of suicide is considerable. Although a broad therapeutic armamentarium for treatment of major depressive episodes (MDE) is available, still about one-third of patients treated for the condition do not respond satisfactorily to the first antidepressant described. Incomplete treatment response or treatment resistance have been described commonly in up to 30 % of the treated patient population, and may even as high as 60 % if treatment resistant depression (TRD) is defined as absence of remission. However, whereas the clinical picture of TRD is common in everyday practice, the conceptual elaboration and definition of clear criteria for incomplete response and TRD has been limited. In a clinical pragmatic view a patient is considered suffering from TRD when consecutive treatment with two products of different pharmacological classes, used for a sufficient length of time at an adequate dose, fail to induce an acceptable effect. As no specific treatments have been approved for this condition and scientific data base is limited, TRD is mentioned in the guideline on treatment of depression, however, no specific guidance has been given (CPMP/EWP/518/97 rev.1). Recently new diagnostic criteria for TRD including operationalizing severity of resistance have been suggested and in scientific advice procedures possible study designs have been proposed.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our clients to define a drug development target, define a drug development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it. If you want to know more don’t hesitate to get in touch.

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